The American Diabetes Association®, the nation's leading voluntary health organization in the fight to Stop Diabetes®, praises Congress for reauthorizing the Special Diabetes Program. The renewal, which was part of the Medicare and Medicaid Extenders Act of 2010, will ensure the Special Diabetes Program for Indians (SDPI) and the Special Diabetes Programs for Type 1 Diabetes (SDP-Type1) continue through September 2013. The measure will provide $150 million in funding per year to each program. Nearly 24 million Americans are living with diabetes and another 57 million have prediabetes. Recently, the Centers for Disease Control and Prevention (CDC) released a report stating that if current trends continue, one in three Americans will have diabetes by the year 2050. Diabetes is among the leading causes of death by disease in the United States. It is a leading cause of heart disease, stroke, blindness, kidney disease, and amputation.
SDPI provides prevention, education and treatment programs in Native American communities. American Indians and Alaska Natives have the highest age-adjusted prevalence of diabetes among all U.S. racial and ethnic groups, where diabetes is four to eight times more common than in the general population. Studies have demonstrated that SDPI's prevention and treatment efforts have contributed to significant reductions in diabetes complications in these targeted populations.
"We applaud the extension of the Special Diabetes Programs," said Gale Marshall, Chair, American Diabetes Association's Awakening the Spirit Native American initiative. "The Special Diabetes Program for Indians provides for more than 450 community-directed programs, allowing local tribes and health programs to set priorities that meet their needs, including prevention activities or treatment. Because of these education and treatment programs, the American Indian and Alaskan Native communities have stories of hope and progress in facing the battle against diabetes."
The Special Diabetes Programs for Type 1 Diabetes provides funding for groundbreaking type 1 diabetes research. Clinical research supported by this program has demonstrated tangible results -- from delaying the full onset of type 1 diabetes in newly diagnosed patients to gaining insight on the underlying causes of diabetes and halting or reversing costly complications such as diabetic eye disease.
"The Special Diabetes Programs for Type 1 Diabetes is a vital federal effort that is bringing us closer to a cure for this epidemic," said Janel Wright, National Chair, Advocacy Committee, American Diabetes Association. "This cost-effective program provides crucial funding for research and results in real advances for people living with type 1 diabetes."
суббота, 14 мая 2011 г.
$1.3 Million Grant For New Tests For Potential Obesity/Diabetes Treatment Awarded To Scripps Florida
The Scripps Research Institute has been awarded a $1.3 million grant by the National Institutes of Health (NIH) to develop a series of tests at its Florida campus to help explore the potential of a protein that has emerged as a highly attractive target for the treatment of obesity and Type 2 diabetes.
Patricia McDonald, an associate scientific director in the Translational Research Institute at Scripps Florida and an assistant professor in the Department of Molecular Therapeutics, is the principal investigator for the three-year project funded by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
"Because obesity and diabetes are two of the most serious health problems facing us, the need for novel treatments has never been greater," McDonald said. "Some recent studies in animal models have shown that activating the G protein-coupled receptor GPR119 improves glucose homeostasis or balance, while positively affecting both food intake and weight gain. This funding will help us design new assays that will explore the overall potential of GPR119 - and may one day lead to more effective treatments."
G protein-coupled receptors (GPCRs) are the largest and most diverse protein family in the human genome. They transduce or convert extracellular stimuli including neurotransmitters, light, hormones, lipids, and peptides into intracellular signals through a number of signaling pathways. Approximately one third, and perhaps as many as half, of currently marketed drugs are designed to target these receptors.
GPR119 is expressed predominantly in the pancreas and gut of humans and rodents and in the rat brain. When activated, the receptor promotes secretion of a specific hormone, called Glucagon-Like Peptide-1 (GLP-1), in the intestines, which in turn increases insulin secretion from the pancreas; both are key components in regulating the balance of glucose in the body. Although some modulators of GPR119 have been discovered, they do not necessarily mimic the receptor's natural ligand and have thus turned out to be mostly unsuitable for use in studying the receptor's biology and function.
"In terms of treating metabolic disease through modulation of GPCRs," McDonald said, "an obvious candidate such as the GLP-1 receptor has been a historically difficult target to track with small molecules, but GPR119 is much more amenable to modulation, plus it also regulates the GLP-1 axis, which is what makes it such a potentially valuable target in diabetes and obesity. We chose this particular receptor for those reasons - and the fact that it's being studied extensively by the pharmaceutical industry."
McDonald hopes that once the new assays are developed, and molecular probes created, the process will lead to the identification of small molecule compounds that can be used therapeutically. The probes themselves might even have potential in this regard.
"We'll be studying these probes to see if they have any drug-like properties, particularly if they show any significant activity against the GPR119 receptor," she said. "The obvious goal would be to improve a probe's therapeutic qualities - oral bioavailability, for example - while keeping its high level of activity, a process that can be a lot more difficult than it sounds."
Expanding Knowledge in the Field
With the human genome sequenced, science now has a good handle on just how many GPCRs exist - at least 1,000 or more. Of those, McDonald said, scientists have a good understanding of what approximately 200 of them actually do and what activates them; another 600 or so are involved in taste and smell. The remaining receptors are known as orphan receptors, whose function and natural ligands have yet to be discovered (also a receptor class that the McDonald lab is actively pursuing).
"We want to look at developing assay environments that are more physiologically relevant to the disease state in question," she said, "to make them more akin to what's really going on in the whole animal. We hope that the in vitro pharmacology that we uncover in GPR119 will help bridge the gap between the limits of cell-based assays and in vivo studies. That's why this funding is so important to eventually find more effective treatments for diabetes and obesity."
In her work, McDonald collaborates with the medicinal chemists at Scripps Florida.
"When small molecule candidates demonstrate some sort of efficacy in our cell-based assays, we work very closely with the chemists to improve their efficacy," she said. "The chemists modify these molecules and then they cycle back to the biologists and our assays for further evaluation. It's a very symbiotic relationship."
Patricia McDonald, an associate scientific director in the Translational Research Institute at Scripps Florida and an assistant professor in the Department of Molecular Therapeutics, is the principal investigator for the three-year project funded by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
"Because obesity and diabetes are two of the most serious health problems facing us, the need for novel treatments has never been greater," McDonald said. "Some recent studies in animal models have shown that activating the G protein-coupled receptor GPR119 improves glucose homeostasis or balance, while positively affecting both food intake and weight gain. This funding will help us design new assays that will explore the overall potential of GPR119 - and may one day lead to more effective treatments."
G protein-coupled receptors (GPCRs) are the largest and most diverse protein family in the human genome. They transduce or convert extracellular stimuli including neurotransmitters, light, hormones, lipids, and peptides into intracellular signals through a number of signaling pathways. Approximately one third, and perhaps as many as half, of currently marketed drugs are designed to target these receptors.
GPR119 is expressed predominantly in the pancreas and gut of humans and rodents and in the rat brain. When activated, the receptor promotes secretion of a specific hormone, called Glucagon-Like Peptide-1 (GLP-1), in the intestines, which in turn increases insulin secretion from the pancreas; both are key components in regulating the balance of glucose in the body. Although some modulators of GPR119 have been discovered, they do not necessarily mimic the receptor's natural ligand and have thus turned out to be mostly unsuitable for use in studying the receptor's biology and function.
"In terms of treating metabolic disease through modulation of GPCRs," McDonald said, "an obvious candidate such as the GLP-1 receptor has been a historically difficult target to track with small molecules, but GPR119 is much more amenable to modulation, plus it also regulates the GLP-1 axis, which is what makes it such a potentially valuable target in diabetes and obesity. We chose this particular receptor for those reasons - and the fact that it's being studied extensively by the pharmaceutical industry."
McDonald hopes that once the new assays are developed, and molecular probes created, the process will lead to the identification of small molecule compounds that can be used therapeutically. The probes themselves might even have potential in this regard.
"We'll be studying these probes to see if they have any drug-like properties, particularly if they show any significant activity against the GPR119 receptor," she said. "The obvious goal would be to improve a probe's therapeutic qualities - oral bioavailability, for example - while keeping its high level of activity, a process that can be a lot more difficult than it sounds."
Expanding Knowledge in the Field
With the human genome sequenced, science now has a good handle on just how many GPCRs exist - at least 1,000 or more. Of those, McDonald said, scientists have a good understanding of what approximately 200 of them actually do and what activates them; another 600 or so are involved in taste and smell. The remaining receptors are known as orphan receptors, whose function and natural ligands have yet to be discovered (also a receptor class that the McDonald lab is actively pursuing).
"We want to look at developing assay environments that are more physiologically relevant to the disease state in question," she said, "to make them more akin to what's really going on in the whole animal. We hope that the in vitro pharmacology that we uncover in GPR119 will help bridge the gap between the limits of cell-based assays and in vivo studies. That's why this funding is so important to eventually find more effective treatments for diabetes and obesity."
In her work, McDonald collaborates with the medicinal chemists at Scripps Florida.
"When small molecule candidates demonstrate some sort of efficacy in our cell-based assays, we work very closely with the chemists to improve their efficacy," she said. "The chemists modify these molecules and then they cycle back to the biologists and our assays for further evaluation. It's a very symbiotic relationship."
ARKRAY USA Receives FDA Clearance On GLUCOCARD(TM) 01 Blood Glucose Monitoring System
ARKRAY USA, Inc. announced 510(k)
clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System.
GLUCOCARD(TM) 01
This new, affordable system requires no coding, displays results in 7
seconds, and requires a tiny 0.3 microliter sample size. GLUCOCARD(TM) 01
is AST approved and has a 360-count test memory with time and date stamp.
It also features a large, easy-to-read display for better viewing of test
results. The GLUCOCARD(TM) 01 is distinguished by its leading edge design
and technology. Recent clinical data showed GLUCOCARD(TM) 01 to be highly
accurate.
"ARKRAY is excited to announce a new addition to our growing line of
GLUCOCARD(TM) blood glucose monitoring systems. The novel GLUCOCARD(TM) 01
system follows the GLUCOCARD(TM) brand image of sleek, compact, and
discreet. The GLUCOCARD(TM) 01 appearance is similar to leading cell phone
designs and unlike other glucose monitors on the market," said Jonathan
Chapman, President of ARKRAY USA, Inc. "We look forward to building off the
GLUCOCARD(TM) 01 technology and launching further systems later this year
that will utilize the identical test strip."
About ARKRAY USA
ARKRAY has been a pioneer for nearly 50 years in the field of automated
analysis from laboratory and point-of-care systems to home use patient
self-testing systems. ARKRAY's primary focus throughout that time has been
diabetes, developing the world's first hand held blood glucose meter (late
1960s) and the world's first HbA1c analyzer (1982). ARKRAY is one of the
few diabetes testing companies in the US market today that undertakes
in-house each step of the development process to bring products to market.
ARKRAY is among the leading medical device companies noted for their
patent-based intellectual property by Patent Board (Wall Street Journal
6/17/08). Worldwide, ARKRAY is the 5th largest blood glucose meter
manufacturer.
ARKRAY USA
arkrayusa
clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System.
GLUCOCARD(TM) 01
This new, affordable system requires no coding, displays results in 7
seconds, and requires a tiny 0.3 microliter sample size. GLUCOCARD(TM) 01
is AST approved and has a 360-count test memory with time and date stamp.
It also features a large, easy-to-read display for better viewing of test
results. The GLUCOCARD(TM) 01 is distinguished by its leading edge design
and technology. Recent clinical data showed GLUCOCARD(TM) 01 to be highly
accurate.
"ARKRAY is excited to announce a new addition to our growing line of
GLUCOCARD(TM) blood glucose monitoring systems. The novel GLUCOCARD(TM) 01
system follows the GLUCOCARD(TM) brand image of sleek, compact, and
discreet. The GLUCOCARD(TM) 01 appearance is similar to leading cell phone
designs and unlike other glucose monitors on the market," said Jonathan
Chapman, President of ARKRAY USA, Inc. "We look forward to building off the
GLUCOCARD(TM) 01 technology and launching further systems later this year
that will utilize the identical test strip."
About ARKRAY USA
ARKRAY has been a pioneer for nearly 50 years in the field of automated
analysis from laboratory and point-of-care systems to home use patient
self-testing systems. ARKRAY's primary focus throughout that time has been
diabetes, developing the world's first hand held blood glucose meter (late
1960s) and the world's first HbA1c analyzer (1982). ARKRAY is one of the
few diabetes testing companies in the US market today that undertakes
in-house each step of the development process to bring products to market.
ARKRAY is among the leading medical device companies noted for their
patent-based intellectual property by Patent Board (Wall Street Journal
6/17/08). Worldwide, ARKRAY is the 5th largest blood glucose meter
manufacturer.
ARKRAY USA
arkrayusa
Grow It, Make It, Fake It -- Diabetes Forecast Offers "Do It Yourself" Tips To Better Eating
These days the quest for good health is in full swing, and we all want to eat better, know what ingredients are in our foods -- and still have something in our wallets. The June issue of Diabetes Forecast , the consumer magazine of the American Diabetes Association, features a special food section with three do-it-yourself areas: grow it, make it and fake it. Complete with mouthwatering photos and recipes, this special section is sure to help you find new and delicious projects that you can call your own.
Grow it! Did you know that the best-tasting food can come straight from your yard -- or even your patio or balcony? Diabetes Forecast turns to backyard and urban gardening experts to provide you with the essential information for getting started. "Some people have such a big vision of what they want their garden to be," says Julie Thomson-Adolf, owner of the South Carolina company Garden Delights. "Start small so you don't get frustrated." From sun to soil and seeds to schedules, this feature -- complete with recipes for your garden-fresh return -- will inspire you to get your hands dirty!
Make it! What's the difference between homemade crackers and store-bought ones? A whole lot of syllables! Avoid the tongue-twisting ingredients listed on the packaging, and take control over what goes in the foods you eat. You can also make adjustments to fit your dietary needs and taste buds. Diabetes Forecast provides you with some simple recipes for homemade goods, including barbecue sauce, granola, crackers, nut butter (peanut, almond, hazelnut or whatever you prefer!), popsicles, and chicken, beef or fish stock. This also includes a bonus feature with steps for canning foods at home.
Fake it! Need to put together a meal that looks like a million bucks but only costs a few? Try these recipes out and turn your home into a four-star restaurant with little work involved.
- Four-Mushroom Salad: Summer brings a bounty of inexpensive mushroom varieties, which are delightfully showcased in this elegant medley.
- Shrimp-Stuffed Flounder: Fill and rolled, these fillets become a restaurant-worthy entr?©e -- except the price.
- Double-Strawberry Meringues: One of the great things about meringues is how impressive they can look but how easy they really are to make. Dress this one up with a swirl of whipped topping or a sprig of mint or basil.
With all the photos, recipes and tips in the June issue of Diabetes Forecast, making the changes necessary to take control of what you eat has never been easier.
This issue of Diabetes Forecast also includes an inspirational story about Malika Bey -- the mother of four children, an employee at three jobs, a person living with type 2 diabetes, and the captain of a team in the Philadelphia Step Out: Walk to Fight Diabetes event. "As a diabetic, sometimes you feel like you're the only one," she says. "But then [at Step Out] you realize, wow, look at everybody. It's nice to know you're part of something bigger than you feel."
The June issue also includes information on other topics, including:
- Sweet Smarts: Watching blood glucose for health
- Double Duty: Treating diabetes and depression at the same time
- Joining Forces: An American Diabetes Association network attorney helps remove legal obstacles to good health
Diabetes Forecast has been America's leading diabetes magazine for more than 60 years, offering the latest news on diabetes research and treatment to provide information, inspiration and support to people with diabetes.
Source
American Diabetes Association
Grow it! Did you know that the best-tasting food can come straight from your yard -- or even your patio or balcony? Diabetes Forecast turns to backyard and urban gardening experts to provide you with the essential information for getting started. "Some people have such a big vision of what they want their garden to be," says Julie Thomson-Adolf, owner of the South Carolina company Garden Delights. "Start small so you don't get frustrated." From sun to soil and seeds to schedules, this feature -- complete with recipes for your garden-fresh return -- will inspire you to get your hands dirty!
Make it! What's the difference between homemade crackers and store-bought ones? A whole lot of syllables! Avoid the tongue-twisting ingredients listed on the packaging, and take control over what goes in the foods you eat. You can also make adjustments to fit your dietary needs and taste buds. Diabetes Forecast provides you with some simple recipes for homemade goods, including barbecue sauce, granola, crackers, nut butter (peanut, almond, hazelnut or whatever you prefer!), popsicles, and chicken, beef or fish stock. This also includes a bonus feature with steps for canning foods at home.
Fake it! Need to put together a meal that looks like a million bucks but only costs a few? Try these recipes out and turn your home into a four-star restaurant with little work involved.
- Four-Mushroom Salad: Summer brings a bounty of inexpensive mushroom varieties, which are delightfully showcased in this elegant medley.
- Shrimp-Stuffed Flounder: Fill and rolled, these fillets become a restaurant-worthy entr?©e -- except the price.
- Double-Strawberry Meringues: One of the great things about meringues is how impressive they can look but how easy they really are to make. Dress this one up with a swirl of whipped topping or a sprig of mint or basil.
With all the photos, recipes and tips in the June issue of Diabetes Forecast, making the changes necessary to take control of what you eat has never been easier.
This issue of Diabetes Forecast also includes an inspirational story about Malika Bey -- the mother of four children, an employee at three jobs, a person living with type 2 diabetes, and the captain of a team in the Philadelphia Step Out: Walk to Fight Diabetes event. "As a diabetic, sometimes you feel like you're the only one," she says. "But then [at Step Out] you realize, wow, look at everybody. It's nice to know you're part of something bigger than you feel."
The June issue also includes information on other topics, including:
- Sweet Smarts: Watching blood glucose for health
- Double Duty: Treating diabetes and depression at the same time
- Joining Forces: An American Diabetes Association network attorney helps remove legal obstacles to good health
Diabetes Forecast has been America's leading diabetes magazine for more than 60 years, offering the latest news on diabetes research and treatment to provide information, inspiration and support to people with diabetes.
Source
American Diabetes Association
American Diabetes Association Announces Tamara Darsow, PhD, As New Vice President, Research Programs
The American Diabetes Association announced that Tamara "Mara" Darsow, PhD, has been named the Association's Vice President of Research Programs. As a part of the Association's Scientific & Medical Division leadership team, Darsow will oversee the research grants programs and research committees, while also providing scientific support for the Association's Research Foundation.
Prior to accepting her position with the Association, Darsow was the Director of External Research Programs and Strategic Relation at Amylin Pharmaceuticals, Inc. In this role she provided oversight of all Amylin external research programs as well as scientific support for Amylin marketing and medical affairs. Previous to her work at Amylin, Darsow was a Damon Runyon Post-Doctoral Fellow at the Salk Institute in La Jolla, California, where she developed and led an independent research program. Darsow has co-authored numerous publications and abstracts, many focusing on type 1 and type 2 diabetes.
"Mara's experience in clinical and basic research, medical communications, and grants program management make her uniquely qualified for her position," said David Kendall, MD, Chief Scientific & Medical Affairs Officer. "We look forward to her contributions towards the Association's research efforts."
In 2010, the American Diabetes Association made $34.1 million available to support the broad spectrum of diabetes research. This funding supported 338 awards at more than 125 leading research institutions in the United States, averaging more than five published papers per currently funded investigator. Over the years, the Association has invested more than $530 million in diabetes research and provided funding for more than 4,000 research projects.
Darsow holds a PhD in Cell and Molecular Biology from the University of California at San Diego and a BS in Microbiology from Montana State University.
Prior to accepting her position with the Association, Darsow was the Director of External Research Programs and Strategic Relation at Amylin Pharmaceuticals, Inc. In this role she provided oversight of all Amylin external research programs as well as scientific support for Amylin marketing and medical affairs. Previous to her work at Amylin, Darsow was a Damon Runyon Post-Doctoral Fellow at the Salk Institute in La Jolla, California, where she developed and led an independent research program. Darsow has co-authored numerous publications and abstracts, many focusing on type 1 and type 2 diabetes.
"Mara's experience in clinical and basic research, medical communications, and grants program management make her uniquely qualified for her position," said David Kendall, MD, Chief Scientific & Medical Affairs Officer. "We look forward to her contributions towards the Association's research efforts."
In 2010, the American Diabetes Association made $34.1 million available to support the broad spectrum of diabetes research. This funding supported 338 awards at more than 125 leading research institutions in the United States, averaging more than five published papers per currently funded investigator. Over the years, the Association has invested more than $530 million in diabetes research and provided funding for more than 4,000 research projects.
Darsow holds a PhD in Cell and Molecular Biology from the University of California at San Diego and a BS in Microbiology from Montana State University.
News From The American Chemical Society, May 13, 2009
Advance in detecting melamine-adulterated food
Researchers in Indiana are reporting an advance toward faster, more sensitive tests for detecting melamine, the substance that killed at least 6 children and sickened 300,000 children in China who drank milk and infant formula adulterated with the substance. The improved tests may ease global concerns about food safety, the researchers say. Their report is scheduled for the May 27 issue of ACS' Journal of Agricultural and Food Chemistry, a bi-weekly publication.
In the new study, Lisa Mauer and colleagues note that tests already exist for melamine, which is widely used in plastics. Certain food manufacturers, however, have added melamine to food products marketed for humans and domestic pets to boost apparent protein content. Conventional tests, however, tend to be too slow, insensitive, and too complex for large-scale food screening applications. Researchers say that better detection tests are needed, particularly in the wake of new U.S. Food and Drug Administration (FDA) guidelines limiting melamine in dairy products to 1 part per million (ppm) or less.
The scientists describe a trio of promising detection methods based on near- and mid-infrared spectroscopy, analytical techniques that identify a substance based on its chemical fingerprint when exposed to specific kinds of light. In laboratory studies, the scientists used these tests to screen infant formula spiked with different concentrations of melamine. They found that these methods accurately detected the substance at levels as low as 1 ppm, meeting the new FDA detection guidelines. The techniques take as little as 5 minutes to detect melamine and are relatively simple to use, requiring little or no sample preparation.
ARTICLE: "Melamine Detection in Infant Formula Powder Using Near- and Mid-Infrared Spectroscopy"
CONTACT:
Lisa J. Mauer, Ph.D.
Department of Food Science
Purdue University
West Lafayette, Ind. 47907
Cloud computing brings cost of protein research down-to-earth
The amazingly powerful computers at Amazon - where online customers order books, CDs, and other products - are giving scientists an inexpensive tool to crunch massive amounts of data being generated by efforts to understand proteins. Termed proteomics, the large-scale study of all the proteins in an organism, promises new ways of diagnosing and treating hundreds of diseases. In a report scheduled for the June 5 issue of ACS' monthly Journal of Proteome Research, scientists describe the development of free tools using Amazon's "cloud computing" service that can help shoulder scientists' data crunching needs with its brawny network of computers.
In the report, Brian D. Halligan and colleagues note that a major challenge in proteomics research involves obtaining and maintaining the costly computational infrastructure required for analysis of data. "Cloud computing," using a large network of computers to tackle one complex task, may make this mountain of data easier to manage.
The researchers describe development of a new approach to proteomics data analysis called ViPDAC (virtual proteomics data analysis cluster) that uses Amazon Web Service's inexpensive "cloud computing" service. It allows people to rent processing time on Amazon's powerful servers. The study describes one data analysis that took less than 6 days with ViPDAC, but would have required 140 days on a desktop computer. "For researchers currently without access to large computer resources, this greatly increases the options to analyze their data. They can now undertake more complex analyses or try different approaches that were simply not feasible for them before," the report states.
ARTICLE: "Low Cost, Scalable Proteomics Data Analysis Using Amazon's Cloud Computing Services and Open Source Search Algorithms"
CONTACT:
Brian D. Halligan, Ph.D
Medical College of Wisconsin
Milwaukee, Wisc. 53226
Solving the mystery of how plants survive near Chernobyl
Twenty-two years after the Chernobyl nuclear power station accident in the Ukraine - the worst in history - scientists are reporting insights into the mystery of how plants have managed to adapt and survive in the radioactive soil near Chernobyl. Their research is the first to probe how production of key proteins in plants changes in response to the radioactive environment, according to the report. It is scheduled for the June 5 issue of ACS' Journal of Proteome Research, a monthly publication.
Martin Hajduch and colleagues note in the new study that plants growing in the Chernobyl area following the April 26, 1986 disaster somehow adapted to the radioactive environment and thrived. But until now, nobody knew what biochemical changes in the plants accounted for this miracle and enabled plants to adapt.
The researchers found that soybean plant seeds exposed to radiation produced different amounts and types of protein than seeds from unexposed plants. The proteins protected the seeds from radio-contaminated environment. Interestingly, plants from contaminated fields produced one-third more of a protective protein called betaine aldehyde dehydrogenase - the same protein known to protect human blood from radiation damage.
ARTICLE: "Proteomic Analysis of Mature Soybean Seeds from the Chernobyl Area Suggest Plant Adaptation to the Contaminated Environment"
CONTACT:
Martin Hajduch, Ph.D.
Department of Reproduction and Developmental Biology
Institute of Plant Genetics and Biotechnology
Slovak Academy of Sciences
Slovak Republic
New insights into the mystery of "high risk platelets" from diabetic donors
Amid emerging concerns that blood platelets donated for transfusion by individuals with Type 2 diabetes may be unsafe, scientists are reporting the first detailed identification and analysis of a group of abnormal proteins in platelets from diabetic donors. The study could lead to screening tests to detect and monitor these so-called "high risk platelets," the researchers say. Their study is scheduled for the June 5 issue of ACS' Journal of Proteome Research, a monthly publication. About 18 million people in the United States have Type 2 diabetes, and the disease is spreading with the epidemic of obesity.
David Springer and colleagues point out in the new study that thousands of patients receive potentially lifesaving transfusions of platelets each year to treat bleeding from trauma and for a wide range of medical conditions. Scientists have known that abnormal platelets in the blood of diabetics may predispose these individuals to heart disease. It led to concern that platelets from these individuals stored for transfusion may be less effective and even unsafe. However, scientists know little about how diabetic platelets differ from those of healthy people.
The new study identified 122 proteins that differed in the platelets of individuals with diabetes compared to the platelets of non-diabetics. They also found that freshly collected platelets from diabetics show almost as many abnormal changes (more than 100) in protein content as healthy donor platelets stored for up to 5 days. These findings could lead to new tests for detecting and monitoring abnormal platelets to improve the outcome of blood transfusions from both diabetic and healthy individuals, the researchers say.
ARTICLE: "Platelet Proteome Changes Associated with Diabetes and during Platelet Storage for Transfusion"
CONTACT:
David Springer, Ph.D.
Biological Sciences Division
Pacific Northwest national Laboratory
Richland, Wash. 99352
Revealing a surprising link between diabetes and Alzheimer's disease
Blindness, heart disease, nerve damage, and kidney failure are not the only complications facing the nation's estimated 24 million people with diabetes. Although not widely known, those with the disease face up to double the risk of developing Alzheimer's disease (AD) than non-diabetics, according to an article scheduled for the May 18 issue of Chemical & Engineering News, ACS' weekly newsmagazine.
C&EN senior editor Sophie Rovner explains in the article that people with diabetes tend to have a higher risk of getting AD, and possibly get it at an earlier age, than the general population. Five million people in the United States have Alzheimer's, a brain disorder that causes severe memory loss. Diabetes results from the body's inability to produce or use insulin. Newer research now suggests that insulin is critical for healthy nerve cells in the brain. As the hormone declines in the brains of people with Alzheimer's, so does their memory.
Some research even suggests that diabetes and Alzheimer's are part of the same disease process that affects different parts of the body and that Alzheimer's may be considered "Type 3" diabetes. If so, then doctors might treat Alzheimer's in the same way as diabetes, which includes giving patients insulin or other medications - including so-called "insulin sensitizing" drugs - the article states.
ARTICLE: "Alzheimer's Scary Link To Diabetes"
Researchers in Indiana are reporting an advance toward faster, more sensitive tests for detecting melamine, the substance that killed at least 6 children and sickened 300,000 children in China who drank milk and infant formula adulterated with the substance. The improved tests may ease global concerns about food safety, the researchers say. Their report is scheduled for the May 27 issue of ACS' Journal of Agricultural and Food Chemistry, a bi-weekly publication.
In the new study, Lisa Mauer and colleagues note that tests already exist for melamine, which is widely used in plastics. Certain food manufacturers, however, have added melamine to food products marketed for humans and domestic pets to boost apparent protein content. Conventional tests, however, tend to be too slow, insensitive, and too complex for large-scale food screening applications. Researchers say that better detection tests are needed, particularly in the wake of new U.S. Food and Drug Administration (FDA) guidelines limiting melamine in dairy products to 1 part per million (ppm) or less.
The scientists describe a trio of promising detection methods based on near- and mid-infrared spectroscopy, analytical techniques that identify a substance based on its chemical fingerprint when exposed to specific kinds of light. In laboratory studies, the scientists used these tests to screen infant formula spiked with different concentrations of melamine. They found that these methods accurately detected the substance at levels as low as 1 ppm, meeting the new FDA detection guidelines. The techniques take as little as 5 minutes to detect melamine and are relatively simple to use, requiring little or no sample preparation.
ARTICLE: "Melamine Detection in Infant Formula Powder Using Near- and Mid-Infrared Spectroscopy"
CONTACT:
Lisa J. Mauer, Ph.D.
Department of Food Science
Purdue University
West Lafayette, Ind. 47907
Cloud computing brings cost of protein research down-to-earth
The amazingly powerful computers at Amazon - where online customers order books, CDs, and other products - are giving scientists an inexpensive tool to crunch massive amounts of data being generated by efforts to understand proteins. Termed proteomics, the large-scale study of all the proteins in an organism, promises new ways of diagnosing and treating hundreds of diseases. In a report scheduled for the June 5 issue of ACS' monthly Journal of Proteome Research, scientists describe the development of free tools using Amazon's "cloud computing" service that can help shoulder scientists' data crunching needs with its brawny network of computers.
In the report, Brian D. Halligan and colleagues note that a major challenge in proteomics research involves obtaining and maintaining the costly computational infrastructure required for analysis of data. "Cloud computing," using a large network of computers to tackle one complex task, may make this mountain of data easier to manage.
The researchers describe development of a new approach to proteomics data analysis called ViPDAC (virtual proteomics data analysis cluster) that uses Amazon Web Service's inexpensive "cloud computing" service. It allows people to rent processing time on Amazon's powerful servers. The study describes one data analysis that took less than 6 days with ViPDAC, but would have required 140 days on a desktop computer. "For researchers currently without access to large computer resources, this greatly increases the options to analyze their data. They can now undertake more complex analyses or try different approaches that were simply not feasible for them before," the report states.
ARTICLE: "Low Cost, Scalable Proteomics Data Analysis Using Amazon's Cloud Computing Services and Open Source Search Algorithms"
CONTACT:
Brian D. Halligan, Ph.D
Medical College of Wisconsin
Milwaukee, Wisc. 53226
Solving the mystery of how plants survive near Chernobyl
Twenty-two years after the Chernobyl nuclear power station accident in the Ukraine - the worst in history - scientists are reporting insights into the mystery of how plants have managed to adapt and survive in the radioactive soil near Chernobyl. Their research is the first to probe how production of key proteins in plants changes in response to the radioactive environment, according to the report. It is scheduled for the June 5 issue of ACS' Journal of Proteome Research, a monthly publication.
Martin Hajduch and colleagues note in the new study that plants growing in the Chernobyl area following the April 26, 1986 disaster somehow adapted to the radioactive environment and thrived. But until now, nobody knew what biochemical changes in the plants accounted for this miracle and enabled plants to adapt.
The researchers found that soybean plant seeds exposed to radiation produced different amounts and types of protein than seeds from unexposed plants. The proteins protected the seeds from radio-contaminated environment. Interestingly, plants from contaminated fields produced one-third more of a protective protein called betaine aldehyde dehydrogenase - the same protein known to protect human blood from radiation damage.
ARTICLE: "Proteomic Analysis of Mature Soybean Seeds from the Chernobyl Area Suggest Plant Adaptation to the Contaminated Environment"
CONTACT:
Martin Hajduch, Ph.D.
Department of Reproduction and Developmental Biology
Institute of Plant Genetics and Biotechnology
Slovak Academy of Sciences
Slovak Republic
New insights into the mystery of "high risk platelets" from diabetic donors
Amid emerging concerns that blood platelets donated for transfusion by individuals with Type 2 diabetes may be unsafe, scientists are reporting the first detailed identification and analysis of a group of abnormal proteins in platelets from diabetic donors. The study could lead to screening tests to detect and monitor these so-called "high risk platelets," the researchers say. Their study is scheduled for the June 5 issue of ACS' Journal of Proteome Research, a monthly publication. About 18 million people in the United States have Type 2 diabetes, and the disease is spreading with the epidemic of obesity.
David Springer and colleagues point out in the new study that thousands of patients receive potentially lifesaving transfusions of platelets each year to treat bleeding from trauma and for a wide range of medical conditions. Scientists have known that abnormal platelets in the blood of diabetics may predispose these individuals to heart disease. It led to concern that platelets from these individuals stored for transfusion may be less effective and even unsafe. However, scientists know little about how diabetic platelets differ from those of healthy people.
The new study identified 122 proteins that differed in the platelets of individuals with diabetes compared to the platelets of non-diabetics. They also found that freshly collected platelets from diabetics show almost as many abnormal changes (more than 100) in protein content as healthy donor platelets stored for up to 5 days. These findings could lead to new tests for detecting and monitoring abnormal platelets to improve the outcome of blood transfusions from both diabetic and healthy individuals, the researchers say.
ARTICLE: "Platelet Proteome Changes Associated with Diabetes and during Platelet Storage for Transfusion"
CONTACT:
David Springer, Ph.D.
Biological Sciences Division
Pacific Northwest national Laboratory
Richland, Wash. 99352
Revealing a surprising link between diabetes and Alzheimer's disease
Blindness, heart disease, nerve damage, and kidney failure are not the only complications facing the nation's estimated 24 million people with diabetes. Although not widely known, those with the disease face up to double the risk of developing Alzheimer's disease (AD) than non-diabetics, according to an article scheduled for the May 18 issue of Chemical & Engineering News, ACS' weekly newsmagazine.
C&EN senior editor Sophie Rovner explains in the article that people with diabetes tend to have a higher risk of getting AD, and possibly get it at an earlier age, than the general population. Five million people in the United States have Alzheimer's, a brain disorder that causes severe memory loss. Diabetes results from the body's inability to produce or use insulin. Newer research now suggests that insulin is critical for healthy nerve cells in the brain. As the hormone declines in the brains of people with Alzheimer's, so does their memory.
Some research even suggests that diabetes and Alzheimer's are part of the same disease process that affects different parts of the body and that Alzheimer's may be considered "Type 3" diabetes. If so, then doctors might treat Alzheimer's in the same way as diabetes, which includes giving patients insulin or other medications - including so-called "insulin sensitizing" drugs - the article states.
ARTICLE: "Alzheimer's Scary Link To Diabetes"
Protein Crucial In Diabetes May Be Central Player In Other Diseases Too
Studying a protein already known to play an important role in type 2 diabetes and cancer, genomics researchers have discovered that it may have an even broader role in disease, particularly in other metabolic disorders and heart disease. In finding unsuspected links to other disease-related genes, the scientists may have identified future targets for drug treatments.
The paper appeared online July 17 in the British journal Diabetologia.
"This protein could be a central player in many different diseases and traits," said study leader Struan F.A. Grant, Ph.D., a geneticist at The Children's Hospital of Philadelphia and a faculty member of the University of Pennsylvania School of Medicine. The current finding builds on Grant's 2006 discovery, now widely replicated, that a gene called TCF7L2 is strongly linked to type 2 diabetes.
Type 2 diabetes results either when the pancreas produces insufficient insulin or when the body's insulin-processing cells develop resistance to insulin, causing blood sugar to rise to unhealthy levels.
The TCF7L2 gene carries the code for a transcription factor--also called TCF7L2--a protein that binds to genes and regulates their activity. Exactly how this protein acts to affect diabetes is still unknown. However, Grant noted that there is great scientific interest in identifying which genes the transcription factor regulates. "It may be more feasible to develop drugs aimed at proteins encoded by specific gene classes regulated by TCF7L2 that are more amenable to targeted interventions, rather than aiming at a more ubiquitous transcription factor," he said.
Because variants in the TCF7L2 gene are also associated with risk for different cancers, including colorectal cancers, there was even greater reason to learn details of its biological activity. "Our goal," said Grant, "was to simply uncover the repertoire of genes that this transcription factor controls."
Collaborating with investigators at the University of Pennsylvania, Grant used a technique called ChIP-sequencing, which locates and compiles the DNA sequences of genes to which proteins bind. "This uses the latest-generation sequencing technology that has only recently become feasible, allowing investigators to rapidly sequence at the scale of whole genomes," said Grant. In human cell lines, this ChIP approach identified and mapped DNA sequences of TCF7L2 binding sites at over 1,000 gene locations.
"What was unexpected and striking about our results was that this transcription factor binds to a large number of gene locations already implicated in disease from previous GWAS research," said Grant. In the last five years, GWAS, or genome-wide association studies, have proven to be highly successful in scouring the genome to locate gene sites associated with particular diseases.
"We found an over-representation of genes associated with metabolic disorders, such as diabetes, but also with cardiovascular disorders, such as coronary artery disease and atherosclerosis," Grant added. "We expect to follow up these initial observations with functional research to investigate how these genes operate in these diseases, and whether these genes may become candidates for better therapies. For now, our work suggests that this transcription factor may be a central node in a network of genes associated not only with type 2 diabetes, but also exerting its influence much further in contributing to other genetic diseases."
A grant from the Ethel Brown Foerderer Fund for Excellence from The Children's Hospital of Philadelphia supported this study, with added support from the National Institute of Diabetes, Digestive and Kidney Disorders, the Penn Center for Musculoskeletal Disorders, and the University of Pennsylvania Diabetes and Endocrinology Research Center. Grant's co-authors were Klaus H. Kaestner, Ph.D., Jonathan Schug, Ph.D., and Mingyao Li, Ph.D., of the University of Pennsylvania; and Jianhua Zhao, Ph.D., of Children's Hospital.
"Disease-associated loci are significantly over-represented among genes bound by transcription factor 7-like 2 (TCF7L2) in vivo," Diabetologia, published online July 17, 2010. doi: 10.1007/s00125-010-1852-3
The paper appeared online July 17 in the British journal Diabetologia.
"This protein could be a central player in many different diseases and traits," said study leader Struan F.A. Grant, Ph.D., a geneticist at The Children's Hospital of Philadelphia and a faculty member of the University of Pennsylvania School of Medicine. The current finding builds on Grant's 2006 discovery, now widely replicated, that a gene called TCF7L2 is strongly linked to type 2 diabetes.
Type 2 diabetes results either when the pancreas produces insufficient insulin or when the body's insulin-processing cells develop resistance to insulin, causing blood sugar to rise to unhealthy levels.
The TCF7L2 gene carries the code for a transcription factor--also called TCF7L2--a protein that binds to genes and regulates their activity. Exactly how this protein acts to affect diabetes is still unknown. However, Grant noted that there is great scientific interest in identifying which genes the transcription factor regulates. "It may be more feasible to develop drugs aimed at proteins encoded by specific gene classes regulated by TCF7L2 that are more amenable to targeted interventions, rather than aiming at a more ubiquitous transcription factor," he said.
Because variants in the TCF7L2 gene are also associated with risk for different cancers, including colorectal cancers, there was even greater reason to learn details of its biological activity. "Our goal," said Grant, "was to simply uncover the repertoire of genes that this transcription factor controls."
Collaborating with investigators at the University of Pennsylvania, Grant used a technique called ChIP-sequencing, which locates and compiles the DNA sequences of genes to which proteins bind. "This uses the latest-generation sequencing technology that has only recently become feasible, allowing investigators to rapidly sequence at the scale of whole genomes," said Grant. In human cell lines, this ChIP approach identified and mapped DNA sequences of TCF7L2 binding sites at over 1,000 gene locations.
"What was unexpected and striking about our results was that this transcription factor binds to a large number of gene locations already implicated in disease from previous GWAS research," said Grant. In the last five years, GWAS, or genome-wide association studies, have proven to be highly successful in scouring the genome to locate gene sites associated with particular diseases.
"We found an over-representation of genes associated with metabolic disorders, such as diabetes, but also with cardiovascular disorders, such as coronary artery disease and atherosclerosis," Grant added. "We expect to follow up these initial observations with functional research to investigate how these genes operate in these diseases, and whether these genes may become candidates for better therapies. For now, our work suggests that this transcription factor may be a central node in a network of genes associated not only with type 2 diabetes, but also exerting its influence much further in contributing to other genetic diseases."
A grant from the Ethel Brown Foerderer Fund for Excellence from The Children's Hospital of Philadelphia supported this study, with added support from the National Institute of Diabetes, Digestive and Kidney Disorders, the Penn Center for Musculoskeletal Disorders, and the University of Pennsylvania Diabetes and Endocrinology Research Center. Grant's co-authors were Klaus H. Kaestner, Ph.D., Jonathan Schug, Ph.D., and Mingyao Li, Ph.D., of the University of Pennsylvania; and Jianhua Zhao, Ph.D., of Children's Hospital.
"Disease-associated loci are significantly over-represented among genes bound by transcription factor 7-like 2 (TCF7L2) in vivo," Diabetologia, published online July 17, 2010. doi: 10.1007/s00125-010-1852-3
MPs debate diabetes, UK
Diabetes was debated in the UK parliament on Tuesday 16 November. Fittingly, it coincided with the launch of the
government's Public Health White Paper and World Diabetes Day, the theme of which was obesity.
David Amess MP led the debate calling for the need to continue the supply of animal insulin for people with diabetes. Mr
Amess covered a wide range of other issues surrounding diabetes and highlighted the EU Health Council's statement issued in
June 2004 that the scale of diabetes was very serious.
Adrian Sanders MP, the Chair of the All Party Parliamentary Group for Diabetes (APPG), also contributed to the debate by
highlighting the importance of providing people with diabetes with healthy information and clear food labelling.
Benet Middleton, Director of Nations, Regions and Campaigning said: "Debates such as these raise the profile of diabetes in
parliament and help to inform decision makers and others of the true scale and nature of the condition. Both Mr Amess and Mr
Sanders highlighted some crucially important issues that affect many people with diabetes."
Parliamentary Under-Secretary of State for Health, Dr Stephen Ladyman responded on behalf of the Government and congratulated
Diabetes UK on "it's important work into raising awareness and supporting those with diabetes."
diabetes.uk
government's Public Health White Paper and World Diabetes Day, the theme of which was obesity.
David Amess MP led the debate calling for the need to continue the supply of animal insulin for people with diabetes. Mr
Amess covered a wide range of other issues surrounding diabetes and highlighted the EU Health Council's statement issued in
June 2004 that the scale of diabetes was very serious.
Adrian Sanders MP, the Chair of the All Party Parliamentary Group for Diabetes (APPG), also contributed to the debate by
highlighting the importance of providing people with diabetes with healthy information and clear food labelling.
Benet Middleton, Director of Nations, Regions and Campaigning said: "Debates such as these raise the profile of diabetes in
parliament and help to inform decision makers and others of the true scale and nature of the condition. Both Mr Amess and Mr
Sanders highlighted some crucially important issues that affect many people with diabetes."
Parliamentary Under-Secretary of State for Health, Dr Stephen Ladyman responded on behalf of the Government and congratulated
Diabetes UK on "it's important work into raising awareness and supporting those with diabetes."
diabetes.uk
Misonix Announces Participation In Annual Diabetic Foot Global Conference
Misonix, Inc. (Nasdaq: MSON), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has announced their attendance and participation in the annual Diabetic Foot Global Conference (DFCON), which was held in Los Angeles, CA, March 19-21, 2009. In addition to exhibiting its SonicOne(R) Ultrasonic Wound Cleansing and Debridement System to the approximately 950 clinicians in attendance, Misonix provided an educational grant to support a series of workshops dedicated to improving wound debridement techniques, which was led by Vickie R. Driver, MS, DPM, FACFAS, Director of Clinical Research Foot Care at the Boston Medical Center and Boston University School of Medicine. As part of her lecture, Dr. Driver presented details on the advantages of using ultrasonic debridement as compared to other modalities. Post lecture, over 90 attendees participated in "hands on" demonstrations of the SonicOne.
DFCON is dedicated to educating clinical professionals regarding diseases, circulation deficiencies, and non-healing wounds of the lower extremities and the appropriate treatment protocols. Healing of wounds, revascularization, and prevention of amputation are included in their overall strategy for positive patient outcomes.
The SonicOne is an innovative, ultrasonic wound care system that offers tissue specific debridement and cleansing for effective removal of devitalized tissue and fibrin deposits while sparing viable cellular structures. The SonicOne establishes a new standard in advanced wound care and ensures progress towards patient healing.
"Misonix is pleased to demonstrate its commitment to the over one billion dollars per year wound care market by supporting important research and treatment programs like DFCON," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "The wound care product platform is an essential component of our product portfolio, as demonstrated by our commitment to expanding hospital direct sales in the United States and our network of specialty distributors in export markets."
About Misonix:
Misonix, Inc. (Nasdaq: MSON) designs, develops, manufactures and markets therapeutic ultrasonic medical devices and laboratory equipment. Misonix's therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $3 billion annually; Misonix's proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications.
With the exception of historical information contained in this press release, content herein may contain "forward looking statements" that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company's business lines, and other factors discussed in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.
DFCON is dedicated to educating clinical professionals regarding diseases, circulation deficiencies, and non-healing wounds of the lower extremities and the appropriate treatment protocols. Healing of wounds, revascularization, and prevention of amputation are included in their overall strategy for positive patient outcomes.
The SonicOne is an innovative, ultrasonic wound care system that offers tissue specific debridement and cleansing for effective removal of devitalized tissue and fibrin deposits while sparing viable cellular structures. The SonicOne establishes a new standard in advanced wound care and ensures progress towards patient healing.
"Misonix is pleased to demonstrate its commitment to the over one billion dollars per year wound care market by supporting important research and treatment programs like DFCON," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "The wound care product platform is an essential component of our product portfolio, as demonstrated by our commitment to expanding hospital direct sales in the United States and our network of specialty distributors in export markets."
About Misonix:
Misonix, Inc. (Nasdaq: MSON) designs, develops, manufactures and markets therapeutic ultrasonic medical devices and laboratory equipment. Misonix's therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $3 billion annually; Misonix's proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications.
With the exception of historical information contained in this press release, content herein may contain "forward looking statements" that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company's business lines, and other factors discussed in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.
Diabetes Surgery Studied As Potential Treatment For Type 2
Physicians at The University of Texas Health Science Center at Houston (UTHealth) have begun enrollment for a pilot study on a promising surgical approach for the management of Type 2 diabetes.
The procedure being tested is designed for adults who have Type 2 diabetes and who are overweight or obese but not morbidly obese. Millions of Americans have Type 2 diabetes and most are overweight.
Involving surgery to the small intestine and stomach, the procedure, which is called an ileal transposition with sleeve gastrectomy, is intended to improve or resolve Type 2 diabetes. It will be performed at Memorial Hermann-Texas Medical Center.
Type 2 diabetes is a serious health problem and can lead to blindness, limb amputation and heart disease. It is characterized by an elevated blood sugar level associated with the body's inability to produce enough insulin and/or to use it properly.
The researchers' goal is to enhance the ability of a person with Type 2 diabetes to maintain a normal blood sugar level by moving a section of intestine closer to the stomach and reducing the size of the stomach.
Currently, many with Type 2 diabetes must take medication on a daily basis to keep sugar levels in check.
The surgical procedure has been associated with encouraging results in clinical research conducted abroad. If the procedure proves effective, it could allow some people with Type 2 diabetes to cut back or quit their medications.
The objectives of the study include evaluating the safety of the procedure and determining its effectiveness compared to dietary and medical management of Type 2 diabetes.
"No one has compared this surgery directly to medical therapy in a randomized, prospective study like this," said Brad Snyder, M.D., the principal investigator of the study and an assistant professor of surgery at the UTHealth Medical School.
The UTHealth doctors plan to treat 10 people with Type 2 diabetes surgically and 10 medically. Participants will be followed over a two-year period and their outcomes compared.
"If we can get patients into remission and off their medications, then we could open the door for people who want to pursue careers as firefighters, police officers and commercial pilots who may at times be limited by this disease," Snyder said.
An estimated 26 million people in the United States have diabetes, reports the Centers for Disease Control and Prevention. In adults, Type 2 diabetes accounts for about 90 -95 percent of all diagnosed cases of diabetes. Also known as adult onset diabetes and non-insulin dependent diabetes mellitus, Type 2 diabetes is associated with older age, physical inactivity and certain ethnic groups.
"This disease takes a terrible toll on both patients and their families," said Erik Wilson, M.D., a study investigator and an associate professor of surgery at the UTHealth Medical School.
The ileum is the final section of the small intestine and transposition means to change place. Human studies have shown that when you place the ileum closer to the stomach, food from the stomach enters the ileum quickly and hormones that help regulate diabetes are easily stimulated.
In the procedure, surgeons remove a section of the ileum that is about 5 feet in length and reattach it. In addition, they remove about 80 percent of the stomach. It is a "band-aid" procedure that is performed through tiny incisions on the abdomen. As with surgical procedures, there is a risk of complication and the risk is anticipated to be in the 1 to 2 percent range.
The procedure is similar to a treatment for morbid obesity - metabolic and bariatric surgery, which can involve surgery on the stomach and intestines. Research shows that oftentimes Type 2 diabetes improves or resolves in morbidly obese patient following gastric bypass surgery.
"We're not completely sure why people with morbid obesity and Type 2 diabetes experience this improvement following surgery," Snyder said. It could be a combination of the different metabolism of food, the improvement of insulin action or the improvement in insulin secretion, he said.
"This research will help us find some answers and could lead to future treatments," Snyder said.
Metabolic and bariatric surgery is typically limited to people with a body mass index of 40 kg/m?? or more, or a BMI of 35 kg/m?? or more with an obesity-related condition in accordance with National Institutes of Health (NIH) parameters for bariatric surgery. BMI is a calculation based on height and weight.
This pilot study for the surgical management of Type 2 diabetes is restricted to people with a body mass index (BMI) of 25 to 34 kg/m??, which includes people who are overweight or obese. Participants must be between 21 and 55 years of age and being treated for Type 2 diabetes.
The clinical trial team includes Philip Orlander, M.D., a professor of medicine and director of the Division of Endocrinology, Diabetes and Metabolism at the UTHealth Medical School, who medically treats people with Type 2 diabetes. When treating patients, Orlander often begins by recommending they lose weight through conventional means such as restricting their calories and exercising more, as well as taking commonly used medications for diabetes. If that fails and they are eligible for bariatric surgery, Orlander will recommend bariatric surgery as a way to control their Type 2 diabetes.
"The average person with Type 2 diabetes may be on 10 different medications to control their blood sugar, cholesterol and blood pressure," Orlander said. "When we send people to bariatric surgery, a significant portion may be able to stop all of their diabetes, cholesterol and blood pressure medications."
Frank Moody, M.D., a professor of surgery at the UTHealth Medical School with a longtime interest in the surgical treatment of digestive system diseases, is assisting the research team and said the study could shed light on hormones involved in the metabolic process. "The team will be looking at the impact of surgery on the processing of sugars by the diabetic subjects with an expectation of fixing the break in their metabolism," Moody said.
If successful, the next step could involve a large clinical trial, Snyder said. "Our intention is to gather this primary data in a small group to show the safety and likely significance as well."
Snyder, Wilson and Orlander are collaborating on the study with Kelly Wirfel, M.D., an assistant professor of medicine at the UTHealth Medical School. Snyder and Wilson are members of a UT Specialty Surgery Center called Minimally Invasive Surgeons of Texas (MIST) and are on the medical staff of Memorial Hermann-TMC. Wilson is the director of MIST, chief of Elective General Surgery for the UTHealth Medical School and medical director of Bariatric Surgery for Memorial Hermann-TMC.
The study is titled "A Surgical Approach to the Management of Type 2 Diabetes Mellitus in Patients with a BMI between 25-34 kg/m??." The study was approved by the UTHealth Committee for the Protection of Human Subjects and is anticipated to take about three years to complete.
The procedure being tested is designed for adults who have Type 2 diabetes and who are overweight or obese but not morbidly obese. Millions of Americans have Type 2 diabetes and most are overweight.
Involving surgery to the small intestine and stomach, the procedure, which is called an ileal transposition with sleeve gastrectomy, is intended to improve or resolve Type 2 diabetes. It will be performed at Memorial Hermann-Texas Medical Center.
Type 2 diabetes is a serious health problem and can lead to blindness, limb amputation and heart disease. It is characterized by an elevated blood sugar level associated with the body's inability to produce enough insulin and/or to use it properly.
The researchers' goal is to enhance the ability of a person with Type 2 diabetes to maintain a normal blood sugar level by moving a section of intestine closer to the stomach and reducing the size of the stomach.
Currently, many with Type 2 diabetes must take medication on a daily basis to keep sugar levels in check.
The surgical procedure has been associated with encouraging results in clinical research conducted abroad. If the procedure proves effective, it could allow some people with Type 2 diabetes to cut back or quit their medications.
The objectives of the study include evaluating the safety of the procedure and determining its effectiveness compared to dietary and medical management of Type 2 diabetes.
"No one has compared this surgery directly to medical therapy in a randomized, prospective study like this," said Brad Snyder, M.D., the principal investigator of the study and an assistant professor of surgery at the UTHealth Medical School.
The UTHealth doctors plan to treat 10 people with Type 2 diabetes surgically and 10 medically. Participants will be followed over a two-year period and their outcomes compared.
"If we can get patients into remission and off their medications, then we could open the door for people who want to pursue careers as firefighters, police officers and commercial pilots who may at times be limited by this disease," Snyder said.
An estimated 26 million people in the United States have diabetes, reports the Centers for Disease Control and Prevention. In adults, Type 2 diabetes accounts for about 90 -95 percent of all diagnosed cases of diabetes. Also known as adult onset diabetes and non-insulin dependent diabetes mellitus, Type 2 diabetes is associated with older age, physical inactivity and certain ethnic groups.
"This disease takes a terrible toll on both patients and their families," said Erik Wilson, M.D., a study investigator and an associate professor of surgery at the UTHealth Medical School.
The ileum is the final section of the small intestine and transposition means to change place. Human studies have shown that when you place the ileum closer to the stomach, food from the stomach enters the ileum quickly and hormones that help regulate diabetes are easily stimulated.
In the procedure, surgeons remove a section of the ileum that is about 5 feet in length and reattach it. In addition, they remove about 80 percent of the stomach. It is a "band-aid" procedure that is performed through tiny incisions on the abdomen. As with surgical procedures, there is a risk of complication and the risk is anticipated to be in the 1 to 2 percent range.
The procedure is similar to a treatment for morbid obesity - metabolic and bariatric surgery, which can involve surgery on the stomach and intestines. Research shows that oftentimes Type 2 diabetes improves or resolves in morbidly obese patient following gastric bypass surgery.
"We're not completely sure why people with morbid obesity and Type 2 diabetes experience this improvement following surgery," Snyder said. It could be a combination of the different metabolism of food, the improvement of insulin action or the improvement in insulin secretion, he said.
"This research will help us find some answers and could lead to future treatments," Snyder said.
Metabolic and bariatric surgery is typically limited to people with a body mass index of 40 kg/m?? or more, or a BMI of 35 kg/m?? or more with an obesity-related condition in accordance with National Institutes of Health (NIH) parameters for bariatric surgery. BMI is a calculation based on height and weight.
This pilot study for the surgical management of Type 2 diabetes is restricted to people with a body mass index (BMI) of 25 to 34 kg/m??, which includes people who are overweight or obese. Participants must be between 21 and 55 years of age and being treated for Type 2 diabetes.
The clinical trial team includes Philip Orlander, M.D., a professor of medicine and director of the Division of Endocrinology, Diabetes and Metabolism at the UTHealth Medical School, who medically treats people with Type 2 diabetes. When treating patients, Orlander often begins by recommending they lose weight through conventional means such as restricting their calories and exercising more, as well as taking commonly used medications for diabetes. If that fails and they are eligible for bariatric surgery, Orlander will recommend bariatric surgery as a way to control their Type 2 diabetes.
"The average person with Type 2 diabetes may be on 10 different medications to control their blood sugar, cholesterol and blood pressure," Orlander said. "When we send people to bariatric surgery, a significant portion may be able to stop all of their diabetes, cholesterol and blood pressure medications."
Frank Moody, M.D., a professor of surgery at the UTHealth Medical School with a longtime interest in the surgical treatment of digestive system diseases, is assisting the research team and said the study could shed light on hormones involved in the metabolic process. "The team will be looking at the impact of surgery on the processing of sugars by the diabetic subjects with an expectation of fixing the break in their metabolism," Moody said.
If successful, the next step could involve a large clinical trial, Snyder said. "Our intention is to gather this primary data in a small group to show the safety and likely significance as well."
Snyder, Wilson and Orlander are collaborating on the study with Kelly Wirfel, M.D., an assistant professor of medicine at the UTHealth Medical School. Snyder and Wilson are members of a UT Specialty Surgery Center called Minimally Invasive Surgeons of Texas (MIST) and are on the medical staff of Memorial Hermann-TMC. Wilson is the director of MIST, chief of Elective General Surgery for the UTHealth Medical School and medical director of Bariatric Surgery for Memorial Hermann-TMC.
The study is titled "A Surgical Approach to the Management of Type 2 Diabetes Mellitus in Patients with a BMI between 25-34 kg/m??." The study was approved by the UTHealth Committee for the Protection of Human Subjects and is anticipated to take about three years to complete.
Potential Target Identified For Treatment Of Obesity-Related Diseases
EVMS scientists recently presented preliminary research findings that identify a specific gene as a potential new target for treating obesity-related diseases.
Two research studies funded by grants from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) examined the role of a gene called STAT4 in the development of Type 2 diabetes and other obesity-related cardiovascular diseases. The research was presented at the 2010 annual meeting of the American Heart Association's Council on Atherosclerosis, Thrombosis and Vascular Biology.
"We've known for some time that STAT4 is a 'gene switch,' meaning it is one of the genes that regulates or 'turns on' immune cells. But, our preliminary findings indicate that STAT4 is also involved in the metabolic process," says Anca D. Dobrian, PhD, assistant professor of physiology and lead author of one of the studies.
"Specifically, we've found that STAT4 appears to be involved in insulin resistance as well as the development of atherosclerosis," adds Elena V. Galkina, PhD, assistant professor of microbiology and molecular cell biology. "Assuming these results in rodent-models hold true for humans, STAT4 offers a potentially attractive target for therapy."
Early findings in these studies indicate that insulin resistance and atherosclerosis, a condition characterized by the thickening of artery walls due to fatty plaque deposits, occur in conjunction with elevated levels of STAT4.
The researchers learned that eliminating STAT4 in rodent models reduced the development of atherosclerosis. Similarly, eliminating STAT4 in rodent models given a high-fat diet revealed that while the rodents gained the same amount of weight as rodents with the gene, they did not develop insulin resistance - which is a risk factor for Type 2 diabetes and other heart problems.
"Basically," says Jerry Nadler, MD, director of the EVMS Strelitz Diabetes Center, chair of internal medicine and co-author on both papers, "it appears that excess STAT4 is working in hyper-drive, leading to inflamed fat which can produce these problems. This is significant because prior to this study, no one knew that STAT4 was involved in insulin resistance or atherosclerosis."
These findings lay the groundwork for pivotal follow-up studies on the relationship between metabolic responses and immunity.
"Now that we know STAT4 is a factor," Dr. Dobrian says, "the next steps will be to work on better understanding the mechanisms behind it with the ultimate goal of developing a drug that blocks or inhibits STAT4, without eliminating it entirely. "
The doctors say that STAT 4 is a particularly attractive target for treatment because it exists in only a few cell types throughout the body, and, therefore, any drug that regulates the gene's expression to maintain normal levels is less likely to cause other side effects.
"This is an important first step in identifying a new target for treatment of the most urgent health problem throughout not only the United States, but much of the developed world," Dr. Galkina says. "If we can develop a way to reduce the health problems associated with obesity, we can save a lot of people."
Drs. Galkina and Dobrian also are funded by research grants from the American Heart Association.
Two research studies funded by grants from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) examined the role of a gene called STAT4 in the development of Type 2 diabetes and other obesity-related cardiovascular diseases. The research was presented at the 2010 annual meeting of the American Heart Association's Council on Atherosclerosis, Thrombosis and Vascular Biology.
"We've known for some time that STAT4 is a 'gene switch,' meaning it is one of the genes that regulates or 'turns on' immune cells. But, our preliminary findings indicate that STAT4 is also involved in the metabolic process," says Anca D. Dobrian, PhD, assistant professor of physiology and lead author of one of the studies.
"Specifically, we've found that STAT4 appears to be involved in insulin resistance as well as the development of atherosclerosis," adds Elena V. Galkina, PhD, assistant professor of microbiology and molecular cell biology. "Assuming these results in rodent-models hold true for humans, STAT4 offers a potentially attractive target for therapy."
Early findings in these studies indicate that insulin resistance and atherosclerosis, a condition characterized by the thickening of artery walls due to fatty plaque deposits, occur in conjunction with elevated levels of STAT4.
The researchers learned that eliminating STAT4 in rodent models reduced the development of atherosclerosis. Similarly, eliminating STAT4 in rodent models given a high-fat diet revealed that while the rodents gained the same amount of weight as rodents with the gene, they did not develop insulin resistance - which is a risk factor for Type 2 diabetes and other heart problems.
"Basically," says Jerry Nadler, MD, director of the EVMS Strelitz Diabetes Center, chair of internal medicine and co-author on both papers, "it appears that excess STAT4 is working in hyper-drive, leading to inflamed fat which can produce these problems. This is significant because prior to this study, no one knew that STAT4 was involved in insulin resistance or atherosclerosis."
These findings lay the groundwork for pivotal follow-up studies on the relationship between metabolic responses and immunity.
"Now that we know STAT4 is a factor," Dr. Dobrian says, "the next steps will be to work on better understanding the mechanisms behind it with the ultimate goal of developing a drug that blocks or inhibits STAT4, without eliminating it entirely. "
The doctors say that STAT 4 is a particularly attractive target for treatment because it exists in only a few cell types throughout the body, and, therefore, any drug that regulates the gene's expression to maintain normal levels is less likely to cause other side effects.
"This is an important first step in identifying a new target for treatment of the most urgent health problem throughout not only the United States, but much of the developed world," Dr. Galkina says. "If we can develop a way to reduce the health problems associated with obesity, we can save a lot of people."
Drs. Galkina and Dobrian also are funded by research grants from the American Heart Association.
Universities Target American Indians For Diabetes Study, Encourage Minority Students To Obtain Science, Medical Careers
University of Oklahoma: The university's Health Sciences Center has worked closely with the Absentee Shawnee, Chickasaw and Choctaw American Indian tribes in the state to encourage participation in the national Treatment Options for Type 2 Diabetes in Adolescents and Youth study, the Oklahoman reports. American Indians make up 40% of participants in the university's study, and the university has enrolled more participants than any of the study's 12 other sites (Raymond, Oklahoman, 3/16).
Xavier University of Louisiana: Xavier on Wednesday began a three-day symposium -- sponsored by the Association of Minority Health Professions Schools -- that seeks to encourage students to pursue careers in the biomedicine and health care fields, the New Orleans Times-Picayune reports. Roughly 600 students from across the nation were expected to participate in the symposium, which will include sessions with experts in each field, as well as a health profession and career development fair (Pope, New Orleans Times-Picayune, 3/17).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Xavier University of Louisiana: Xavier on Wednesday began a three-day symposium -- sponsored by the Association of Minority Health Professions Schools -- that seeks to encourage students to pursue careers in the biomedicine and health care fields, the New Orleans Times-Picayune reports. Roughly 600 students from across the nation were expected to participate in the symposium, which will include sessions with experts in each field, as well as a health profession and career development fair (Pope, New Orleans Times-Picayune, 3/17).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Is Winter To Blame For Type 1 Diabetes?
Researchers from Finland have found a correlation between new cases of Type 1 diabetes and winter months.
The study analysed data of 31,000 children from 105 diabetes centres across 53 countries found a correlation between the season and the onset of Type 1 diabetes. Of the 42 centres that exhibited this seasonal trend, 28 centres had peaks of diagnosis in winter and 33 had troughs in summer.
Large study, strong correlation
Published in the journal 'Diabetic Medicine', the research also found that diabetes centres further away from the equator were more likely to have greater numbers of new cases in winter. This winter trend was more prevalent in boys, as well as in both sexes from the older age groups (5 to 14 years old).
"Results from previous studies in this area have been conflicting but this larger study shows a stronger correlation which is interesting, especially as we still don't know exactly why Type 1 diabetes develops", said Victoria King, Diabetes UK Research Manager.
"Investigating why we might be seeing this pattern could tell us more about what may be triggering the development of Type 1 diabetes.
"Despite this, the study looked at correlations over a relatively short period of time and not all centres that took part in the study showed the correlation between seasonality and diagnosis of Type 1 diabetes so more data are needed before more definite conclusions can be drawn", said King.
Viral infections
Lead author of the study, Elena Moltchanova, Statistician at the National Institute for Health and Welfare, Helsinki, said:
"Numerous reasons have been suggested for the apparent seasonality of the onset of Type 1 diabetes.
These include a seasonal variation in people's levels of blood glucose and insulin, seasonal viral infections, the fact that young people tend to eat more and do less physical activity during winter months and, similarly, that summer holidays provide a rest from school stress and more opportunity to play outdoors."
Source
Diabetes UK
The study analysed data of 31,000 children from 105 diabetes centres across 53 countries found a correlation between the season and the onset of Type 1 diabetes. Of the 42 centres that exhibited this seasonal trend, 28 centres had peaks of diagnosis in winter and 33 had troughs in summer.
Large study, strong correlation
Published in the journal 'Diabetic Medicine', the research also found that diabetes centres further away from the equator were more likely to have greater numbers of new cases in winter. This winter trend was more prevalent in boys, as well as in both sexes from the older age groups (5 to 14 years old).
"Results from previous studies in this area have been conflicting but this larger study shows a stronger correlation which is interesting, especially as we still don't know exactly why Type 1 diabetes develops", said Victoria King, Diabetes UK Research Manager.
"Investigating why we might be seeing this pattern could tell us more about what may be triggering the development of Type 1 diabetes.
"Despite this, the study looked at correlations over a relatively short period of time and not all centres that took part in the study showed the correlation between seasonality and diagnosis of Type 1 diabetes so more data are needed before more definite conclusions can be drawn", said King.
Viral infections
Lead author of the study, Elena Moltchanova, Statistician at the National Institute for Health and Welfare, Helsinki, said:
"Numerous reasons have been suggested for the apparent seasonality of the onset of Type 1 diabetes.
These include a seasonal variation in people's levels of blood glucose and insulin, seasonal viral infections, the fact that young people tend to eat more and do less physical activity during winter months and, similarly, that summer holidays provide a rest from school stress and more opportunity to play outdoors."
Source
Diabetes UK
CYPHER® Sirolimus-eluting Coronary Stent Comparable To Bypass Surgery In Key Safety Measures In Patients With Diabetes And Multi-Vessel Disease
Data from the largest randomized trial of its kind performed to date indicate that the use of percutaneous coronary intervention (PCI) with the CYPHER® Sirolimus-eluting Coronary Stent was comparable to bypass surgery (coronary artery bypass grafting or CABG) in key safety endpoints in patients with multi-vessel disease and diabetes. These data were presented here recently at the European Society of Cardiology meeting.
The CYPHER® Stent is the only drug-eluting stent with such randomized clinical data indicating that it is comparable to bypass surgery in these key safety areas in patients with diabetes and multi-vessel disease, whose coronary artery disease presents unique challenges.
Data from CARDia (Coronary Artery Revascularization in Diabetes Trial) showed that after one year, there was no significant difference between PCI with the CYPHER® Stent and bypass surgery in terms of death, heart attacks or stroke, the primary endpoints for this study (10.1 percent for the CYPHER® Stent compared to 10.2 percent for bypass surgery; p=0.98).
"The results of CARDia provide important new information to our understanding of the treatment of patients with multi-vessel disease and diabetes who present with coronary artery conditions," said Akhil Kapur, M.D., London Chest Hospital, Barts and London National Health Service Trust, London, UK, and one of the principal investigators.
"This is the largest randomized data set comparing angioplasty and surgery in diabetic patients. The results of this study indicate that PCI with the CYPHER® Stent was comparable to CABG in key safety outcomes in these high risk patients." Aside from providing limited support for the CARDia trial, Cordis Corporation has no financial relationship with Dr. Kapur and the other principal investigators.
Key secondary endpoints, including revascularization (need for another procedure), were remarkably low in both arms. As expected, patients who received the CYPHER® Stent were somewhat more likely to undergo revascularization (7.3 percent versus 2.0 percent; p=0.013). This contributed to low but not statistically different rates of the composite outcome of death, heart attack, stroke and repeat revascularization (15.1 percent for the CYPHER® Stent compared to 11 percent for bypass surgery; p=0.217).
All patients in the study had diabetes and multi-vessel disease and were amenable to either surgery or PCI.
The trial, conducted at 24 medical centers throughout the United Kingdom and Ireland, was designed as a non-inferiority trial. In the discussion of the trial in the hotline session, the CARDia investigators were congratulated on the trial, but it was pointed out that due to enrollment of only 510 of the originally planned 600 patients that there was insufficient power to answer the specific question whether stenting was non-inferior to surgery in this population.
Overall Results Favorable for PCI (the CYPHER® Stent or a Bare Metal Stent)
The CYPHER® Stent portion of this study was part of an overall comparison of PCI versus surgery. The CARDia trial included 510 patients randomized to receive bypass surgery (254 patients) or PCI with either the CYPHER® Stent or a bare metal stent (256 patients). Of those patients who received PCI, 180 patients (71%) were randomized to receive the CYPHER® Stent and 72 were randomized to receive a bare metal stent. The CYPHER® Stent cohort was uniformly numerically lower for all outcomes compared to the overall PCI population.
The composite rate of death, heart attack and stroke at one year was similar between the two groups (11.6 percent for PCI and 10.2 percent for surgery; p=0.63). Specifically, the rates of death for total PCI was 3.2 percent compared to 3.3 percent for bypass surgery (p=0.83) and clinically reported non-fatal heart attacks was 8.4 percent for PCI compared to 5.7 percent for bypass surgery (p=0.25). The rate of stroke showed a trend toward being lower with PCI (0.4 percent) compared to bypass surgery (2.5 percent, p=0.09).
Trial Results Show Benefits of PCI to Bypass Surgery for Patients
For many years, patients with multi-vessel disease and diabetes were treated with coronary bypass surgery, considered to be the gold standard for these difficult-to-treat conditions. However, surgery is associated with higher health care costs as well as a lengthy recovery period. Patients receiving PCI are treated with minimally invasive techniques that greatly reduce both health care costs, as well as the amount of time it takes a patient to recover and resume activities of daily living.
"Prior to this trial, there were limited randomized clinical data directly comparing the CYPHER® Stent to bypass surgery in diabetics so these results are critical to our understanding of how to optimally treat coronary artery disease in patients with diabetes," said Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. "These results are also important because the CYPHER® Stent is now the only drug-eluting stent with randomized clinical data compared to bypass surgery specifically in this difficult-to-treat patient population."
The study was supported by major grants from the Hammersmith Hospitals special trustees, Eli Lilly Corporation, Sanofi Aventis and Cordis Corporation. Further support was provided by Boston Scientific, Medtronic, Guidant and Jomed.
Data Consistent with other Trials of the CYPHER® Stent in Patients with Diabetes
The use of drug-eluting stents in patients with diabetes has been the focus of debate and discussion within the medical community for some time. The data from CARDia are consistent with other clinical trial data on the use of the CYPHER® Stent in patients with diabetes.
According to data appearing recently in the Journal of the American College of Cardiology, in patients with diabetes, the CYPHER® Stent outperformed the Taxus® Stent with significantly lower rates of in-segment restenosis (a reblockage within the stented area), target lesion revascularization (TLR; the need for another interventional procedure) and major adverse events (MACE, a composite of death, heart attack and TLR) at nine months.
In this multi-center randomized clinical trial, the six month rate of in-segment restenosis was more than five times lower for the CYPHER® Stent compared to the Taxus® Stent (4.0 percent vs. 20.8 percent respectively (p < 0.001). Most important for patients and physicians, key clinical outcomes measures were about four times lower for the CYPHER® Stent -- at nine-months, clinically driven TLR for the CYPHER® Stent was 1.5 percent compared to 6.0 percent for the Taxus® Stent (p=0.032) while the composite clinical endpoint of MACE was 2.0 percent for the CYPHER® Stent compared to 8.0 percent for the Taxus® Stent (p=0.010).
The CYPHER® Stent does not have an approved indication for use in patients with diabetes or multi-vessel disease in the United States.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at cypherstent.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at cordis.
(a)Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
(b)The third party trademarks used herein are trademarks of their respective owners.
Cordis Corporation
View drug information on Rapamune.
The CYPHER® Stent is the only drug-eluting stent with such randomized clinical data indicating that it is comparable to bypass surgery in these key safety areas in patients with diabetes and multi-vessel disease, whose coronary artery disease presents unique challenges.
Data from CARDia (Coronary Artery Revascularization in Diabetes Trial) showed that after one year, there was no significant difference between PCI with the CYPHER® Stent and bypass surgery in terms of death, heart attacks or stroke, the primary endpoints for this study (10.1 percent for the CYPHER® Stent compared to 10.2 percent for bypass surgery; p=0.98).
"The results of CARDia provide important new information to our understanding of the treatment of patients with multi-vessel disease and diabetes who present with coronary artery conditions," said Akhil Kapur, M.D., London Chest Hospital, Barts and London National Health Service Trust, London, UK, and one of the principal investigators.
"This is the largest randomized data set comparing angioplasty and surgery in diabetic patients. The results of this study indicate that PCI with the CYPHER® Stent was comparable to CABG in key safety outcomes in these high risk patients." Aside from providing limited support for the CARDia trial, Cordis Corporation has no financial relationship with Dr. Kapur and the other principal investigators.
Key secondary endpoints, including revascularization (need for another procedure), were remarkably low in both arms. As expected, patients who received the CYPHER® Stent were somewhat more likely to undergo revascularization (7.3 percent versus 2.0 percent; p=0.013). This contributed to low but not statistically different rates of the composite outcome of death, heart attack, stroke and repeat revascularization (15.1 percent for the CYPHER® Stent compared to 11 percent for bypass surgery; p=0.217).
All patients in the study had diabetes and multi-vessel disease and were amenable to either surgery or PCI.
The trial, conducted at 24 medical centers throughout the United Kingdom and Ireland, was designed as a non-inferiority trial. In the discussion of the trial in the hotline session, the CARDia investigators were congratulated on the trial, but it was pointed out that due to enrollment of only 510 of the originally planned 600 patients that there was insufficient power to answer the specific question whether stenting was non-inferior to surgery in this population.
Overall Results Favorable for PCI (the CYPHER® Stent or a Bare Metal Stent)
The CYPHER® Stent portion of this study was part of an overall comparison of PCI versus surgery. The CARDia trial included 510 patients randomized to receive bypass surgery (254 patients) or PCI with either the CYPHER® Stent or a bare metal stent (256 patients). Of those patients who received PCI, 180 patients (71%) were randomized to receive the CYPHER® Stent and 72 were randomized to receive a bare metal stent. The CYPHER® Stent cohort was uniformly numerically lower for all outcomes compared to the overall PCI population.
The composite rate of death, heart attack and stroke at one year was similar between the two groups (11.6 percent for PCI and 10.2 percent for surgery; p=0.63). Specifically, the rates of death for total PCI was 3.2 percent compared to 3.3 percent for bypass surgery (p=0.83) and clinically reported non-fatal heart attacks was 8.4 percent for PCI compared to 5.7 percent for bypass surgery (p=0.25). The rate of stroke showed a trend toward being lower with PCI (0.4 percent) compared to bypass surgery (2.5 percent, p=0.09).
Trial Results Show Benefits of PCI to Bypass Surgery for Patients
For many years, patients with multi-vessel disease and diabetes were treated with coronary bypass surgery, considered to be the gold standard for these difficult-to-treat conditions. However, surgery is associated with higher health care costs as well as a lengthy recovery period. Patients receiving PCI are treated with minimally invasive techniques that greatly reduce both health care costs, as well as the amount of time it takes a patient to recover and resume activities of daily living.
"Prior to this trial, there were limited randomized clinical data directly comparing the CYPHER® Stent to bypass surgery in diabetics so these results are critical to our understanding of how to optimally treat coronary artery disease in patients with diabetes," said Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. "These results are also important because the CYPHER® Stent is now the only drug-eluting stent with randomized clinical data compared to bypass surgery specifically in this difficult-to-treat patient population."
The study was supported by major grants from the Hammersmith Hospitals special trustees, Eli Lilly Corporation, Sanofi Aventis and Cordis Corporation. Further support was provided by Boston Scientific, Medtronic, Guidant and Jomed.
Data Consistent with other Trials of the CYPHER® Stent in Patients with Diabetes
The use of drug-eluting stents in patients with diabetes has been the focus of debate and discussion within the medical community for some time. The data from CARDia are consistent with other clinical trial data on the use of the CYPHER® Stent in patients with diabetes.
According to data appearing recently in the Journal of the American College of Cardiology, in patients with diabetes, the CYPHER® Stent outperformed the Taxus® Stent with significantly lower rates of in-segment restenosis (a reblockage within the stented area), target lesion revascularization (TLR; the need for another interventional procedure) and major adverse events (MACE, a composite of death, heart attack and TLR) at nine months.
In this multi-center randomized clinical trial, the six month rate of in-segment restenosis was more than five times lower for the CYPHER® Stent compared to the Taxus® Stent (4.0 percent vs. 20.8 percent respectively (p < 0.001). Most important for patients and physicians, key clinical outcomes measures were about four times lower for the CYPHER® Stent -- at nine-months, clinically driven TLR for the CYPHER® Stent was 1.5 percent compared to 6.0 percent for the Taxus® Stent (p=0.032) while the composite clinical endpoint of MACE was 2.0 percent for the CYPHER® Stent compared to 8.0 percent for the Taxus® Stent (p=0.010).
The CYPHER® Stent does not have an approved indication for use in patients with diabetes or multi-vessel disease in the United States.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at cypherstent.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at cordis.
(a)Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
(b)The third party trademarks used herein are trademarks of their respective owners.
Cordis Corporation
View drug information on Rapamune.
Chronic Diseases Threaten Economies Across The Globe
A new report from the Oxford Health Alliance (OxHA), a global organisation promoting chronic disease prevention by focusing on lifestyle risk factors, demonstrates that chronic diseases - heart and lung disease, cancer and diabetes - are having a negative economic impact on both the developed and developing world and should thus be adequately addressed by domestic and international policy makers. The report, Chronic disease: an economic perspective, synthesises extensive evidence from across the world and sends out two main messages: first, chronic diseases should be far more prominent on the international development agenda of donors and international organisations, and, second, from an economic perspective, governments are justified to act to prevent chronic diseases.
The economic relevance of chronic diseases has long been ignored, not least because they were deemed to be a problem affecting mostly the elderly and the wealthy. However, today's report offers evidence to show that not only are chronic diseases affecting the poor in developed as well as developing economies, but that they are also taking a heavy toll on working age adults across the globe. In low- and middle-income countries, chronic diseases currently account for about 40% of deaths and 80% of the disease impact for those aged below 60. The report also takes cost of illness studies into account and looks at the economic impact at every level down to households and individuals.
According to economic reports, chronic diseases can exact a toll of up to 6.8% of a country's GDP. In many countries in the developed world, heart disease alone can account for between 1% and 3% of GDP. In developing countries, where there is less evidence, the economic losses also appear to be significant. In China, for example, tobacco consumption and obesity in 1995 imposed costs of 1.5% and 2.1% of GDP, respectively.
Rachel Nugent, director of health and economics at the Population Reference Bureau, Washington DC, and a co-author of the report, stresses: "Given the economic evidence, the role of chronic diseases as both a marker of poverty and as a potential determinant of economic outcomes is becoming increasingly difficult to ignore. Chronic diseases are predicted to become the most common causes of death by 2015 in both the developed and developing world. Despite this, the Millennium Development Goals, which aim to improve the economies of the world's poorest countries, have failed to include them in their list of health priorities."
Along with demonstrating the significance of chronic diseases in economic terms, the OxHA report also discusses the economic rationale for why government is justified to interfere in what many might consider to be the exclusively private sphere of the individual, that is, how people decide to lead their lives, such as in the case of smoking, alcohol consumption, physical inactivity and diet.
As Marc Suhrcke, an economist with the World Health Organization and another author of the report, says: "Personal choice is a great principle that we as economists whole-heartedly support - as long as a few conditions are met (e.g. these actions do no harm to other, people are well-informed, they act rationally, etc.) When these conditions are not met - which is what is happening in a number of chronic disease-relevant areas - then there is a justification for government to step in to improve on the market's failure. This is solely a question of efficiency and has nothing whatsoever to do with the ideologically driven call for the 'nanny state'."
The report also points out that there are many cost-effective interventions available to address the chronic disease burden, with particular focus on developing countries.
Dr Derek Yach, Director of Global Health at the Rockefeller Foundation and a member of the Oxford Health Alliance Board, concludes, "This report should be a wake up call to governments, economists and philanthropists alike to move chronic diseases up their agenda, if not simply for public health reasons, then because of the negative impact they could have on the economy if unchecked. This is never to downplay the huge importance of communicable, child and maternal health conditions such as HIV/AIDS or under-nutrition, but it is to make the point that we cannot continue to ignore chronic disease as a global health priority."
Members of the Oxford Health Alliance's network will meet in Cape Town in two weeks (20-22 November) to formulate strategies for confronting the fast-growing epidemic of chronic disease. To view or listen to the conference live or on demand, visit 3four50.
Notes:
Chronic disease: an economic perspective was authored by Marc Suhrcke, Rachel Nugent, David Stuckler and Lorenzo Rocco on behalf of the Oxford Health Alliance.
The Oxford Health Alliance
Founded in 2002, the Oxford Health Alliance enables experts and activists from different backgrounds to collaborate in order to confront the epidemic of chronic disease through prevention by focusing on three risk factors - tobacco use, diet and physical activity.
OxHA's five focus areas:
The economic argument for prevention: the costs of chronic disease are already vast, and without urgent investment in health preservation the costs will continue to increase. Better health contributes to economic growth.
Prevention in the workplace: chronic disease risk reduction in the workplace can have a major impact on the health of employees and their families, while improving productivity and workforce participation.
Youth, children and future health: the insights and enthusiasm of young people can change perceptions and lifestyles of future generations. Overweight and obese children develop low self-esteem; poor diet causes behaviour problems.
Environmental design for prevention: designers, architects and urban planners can assist in creating an environment in which the healthy choices are the easy choices.
Industry's role in prevention: prevention efforts by companies and industries can have a far-reaching effect on consumers and communities.
Spokespeople
Marc Suhrcke is an economist with the WHO European Office for Investment for Health and Development in Venice, Italy, where he is in charge of the Health and Economic Development workstream.
Rachel Nugent is director of health and economics at the Population Reference Bureau. She is a contributor to the Disease Control Priorities Project in Developing Countries, published in 2006.
Derek Yach is Director of Global Health at the Rockefeller Foundation. He is a former executive director at the World Health Organization.
Contact:
Marisa Pulaski, PR Officer
Oxford Health Alliance
28 Margaret Street
London
W1W 8RZ
For more information please visit: The Oxford Health Alliance.
The economic relevance of chronic diseases has long been ignored, not least because they were deemed to be a problem affecting mostly the elderly and the wealthy. However, today's report offers evidence to show that not only are chronic diseases affecting the poor in developed as well as developing economies, but that they are also taking a heavy toll on working age adults across the globe. In low- and middle-income countries, chronic diseases currently account for about 40% of deaths and 80% of the disease impact for those aged below 60. The report also takes cost of illness studies into account and looks at the economic impact at every level down to households and individuals.
According to economic reports, chronic diseases can exact a toll of up to 6.8% of a country's GDP. In many countries in the developed world, heart disease alone can account for between 1% and 3% of GDP. In developing countries, where there is less evidence, the economic losses also appear to be significant. In China, for example, tobacco consumption and obesity in 1995 imposed costs of 1.5% and 2.1% of GDP, respectively.
Rachel Nugent, director of health and economics at the Population Reference Bureau, Washington DC, and a co-author of the report, stresses: "Given the economic evidence, the role of chronic diseases as both a marker of poverty and as a potential determinant of economic outcomes is becoming increasingly difficult to ignore. Chronic diseases are predicted to become the most common causes of death by 2015 in both the developed and developing world. Despite this, the Millennium Development Goals, which aim to improve the economies of the world's poorest countries, have failed to include them in their list of health priorities."
Along with demonstrating the significance of chronic diseases in economic terms, the OxHA report also discusses the economic rationale for why government is justified to interfere in what many might consider to be the exclusively private sphere of the individual, that is, how people decide to lead their lives, such as in the case of smoking, alcohol consumption, physical inactivity and diet.
As Marc Suhrcke, an economist with the World Health Organization and another author of the report, says: "Personal choice is a great principle that we as economists whole-heartedly support - as long as a few conditions are met (e.g. these actions do no harm to other, people are well-informed, they act rationally, etc.) When these conditions are not met - which is what is happening in a number of chronic disease-relevant areas - then there is a justification for government to step in to improve on the market's failure. This is solely a question of efficiency and has nothing whatsoever to do with the ideologically driven call for the 'nanny state'."
The report also points out that there are many cost-effective interventions available to address the chronic disease burden, with particular focus on developing countries.
Dr Derek Yach, Director of Global Health at the Rockefeller Foundation and a member of the Oxford Health Alliance Board, concludes, "This report should be a wake up call to governments, economists and philanthropists alike to move chronic diseases up their agenda, if not simply for public health reasons, then because of the negative impact they could have on the economy if unchecked. This is never to downplay the huge importance of communicable, child and maternal health conditions such as HIV/AIDS or under-nutrition, but it is to make the point that we cannot continue to ignore chronic disease as a global health priority."
Members of the Oxford Health Alliance's network will meet in Cape Town in two weeks (20-22 November) to formulate strategies for confronting the fast-growing epidemic of chronic disease. To view or listen to the conference live or on demand, visit 3four50.
Notes:
Chronic disease: an economic perspective was authored by Marc Suhrcke, Rachel Nugent, David Stuckler and Lorenzo Rocco on behalf of the Oxford Health Alliance.
The Oxford Health Alliance
Founded in 2002, the Oxford Health Alliance enables experts and activists from different backgrounds to collaborate in order to confront the epidemic of chronic disease through prevention by focusing on three risk factors - tobacco use, diet and physical activity.
OxHA's five focus areas:
The economic argument for prevention: the costs of chronic disease are already vast, and without urgent investment in health preservation the costs will continue to increase. Better health contributes to economic growth.
Prevention in the workplace: chronic disease risk reduction in the workplace can have a major impact on the health of employees and their families, while improving productivity and workforce participation.
Youth, children and future health: the insights and enthusiasm of young people can change perceptions and lifestyles of future generations. Overweight and obese children develop low self-esteem; poor diet causes behaviour problems.
Environmental design for prevention: designers, architects and urban planners can assist in creating an environment in which the healthy choices are the easy choices.
Industry's role in prevention: prevention efforts by companies and industries can have a far-reaching effect on consumers and communities.
Spokespeople
Marc Suhrcke is an economist with the WHO European Office for Investment for Health and Development in Venice, Italy, where he is in charge of the Health and Economic Development workstream.
Rachel Nugent is director of health and economics at the Population Reference Bureau. She is a contributor to the Disease Control Priorities Project in Developing Countries, published in 2006.
Derek Yach is Director of Global Health at the Rockefeller Foundation. He is a former executive director at the World Health Organization.
Contact:
Marisa Pulaski, PR Officer
Oxford Health Alliance
28 Margaret Street
London
W1W 8RZ
For more information please visit: The Oxford Health Alliance.
Researcher Wins Award From American Diabetes Association
A researcher at the University of Rochester Medical Center has won the 2006 Thomas R. Lee Career Development Award from the American Diabetes Association (ADA), which includes an $842,400 grant to study how diabetes dramatically increases risk for cardiovascular disease. The award recognizes the excellence in diabetes-related research achieved by Zheng-Gen Jin, Ph.D., assistant professor in the Department of Medicine and the Cardiovascular Research Institute, and supports his lab's work.
Nearly 21 million Americans have diabetes. The most life-threatening consequences of diabetes are heart diseases and stroke, which strike people with diabetes twice as often as people without the disease. More than 65 percent of deaths in diabetes patients are attributed to heart and vascular disease. Thus, researchers are seeking urgency to understand why people with diabetes are at greater risk. Dr. Jin won the award for his study, titled Molecular Basis for Diabetes-associated endothelial dysfunction, which focuses on how high blood sugar (blood glucose) in diabetes patients contributes to narrowed blood vessels, creating risk for heart attack and stroke.
Dr. Jin was chosen because his ADA grant application was found to have the highest scientific merit in a given fiscal year. The Thomas R. Lee Career Development Award is funded in full by the Estate of Mr. Thomas R. Lee of Norfolk, Virginia, through ADA Research Foundation. The ADA funding for Jin's lab begins this year and runs through 2010.
"I am honored and excited to receive the award because I believe it will help us to improve the understanding of how two deadly diseases are related," Jin said. "Both diabetes and heart disease have reached epidemic levels and are projected to get worse, so we appreciate Mr. Lee's generosity and applaud the ADA's support of the search for better, preventive treatments."
Diabetes Study Details
Diabetes mellitus is a long-term disease where patients lose, or see reduced, their ability to effectively process sugar consumed as food. They develop high blood sugar because the body does not produce (type 1 diabetes) or produces too little (type 2 diabetes) insulin, the enzyme that takes sugar from blood and carries it into the cells where it can be used to produce energy. Diabetes can change the chemical makeup of substances found in the blood, which can cause blood vessels to narrow or to clog completely. This process is called atherosclerosis, or hardening of the arteries, and diabetes seems to speed it up.
Jin's lab is focused on the role of oxidative stress in the development of atherosclerosis in patients with Type 2 diabetes. High blood glucose can stimulate the production of highly reactive molecules called free radicals from cells in blood and in blood vessel walls. Oxidative stress occurs when those free radicals overwhelm the antioxidant defence system in cells and cause unwanted reactions with sensitive molecules (e.g. DNA). Beyond the direct cellular damage, oxidative stress also reduces the bioavailability of nitric oxide (NO). NO signals muscle within blood vessels to relax, widening the artery and increasing blood flow. Less NO means blood vessels are less relaxed and open and more likely to clog. Derived from cells lining blood vessels (vascular endothelial cells), NO is believed to counter atherosclerosis.
High blood glucose in patients with diabetes impairs the performance of NO synthases (NOS), the enzymes that generate NO in response to blood flow, according to theory. Jin hopes to soon understand the molecular mechanisms behind this process on the way to creating new drugs that release more nitric oxide when needed to prevent cardiovascular disease in patients with diabetes.
"Diabetes is on the rise in the United States, yet the available funding for research hasn't increased at the same pace," said Don Wagner, chair of the American Diabetes Association Research Foundation. "That's why we believe it's so important to recognize and support the work of scientists like Dr. Jin, whose cutting-edge research is doing so much to improve the quality of life for people who suffer from this disease."
Contact: Greg Williams
University of Rochester Medical Center
Nearly 21 million Americans have diabetes. The most life-threatening consequences of diabetes are heart diseases and stroke, which strike people with diabetes twice as often as people without the disease. More than 65 percent of deaths in diabetes patients are attributed to heart and vascular disease. Thus, researchers are seeking urgency to understand why people with diabetes are at greater risk. Dr. Jin won the award for his study, titled Molecular Basis for Diabetes-associated endothelial dysfunction, which focuses on how high blood sugar (blood glucose) in diabetes patients contributes to narrowed blood vessels, creating risk for heart attack and stroke.
Dr. Jin was chosen because his ADA grant application was found to have the highest scientific merit in a given fiscal year. The Thomas R. Lee Career Development Award is funded in full by the Estate of Mr. Thomas R. Lee of Norfolk, Virginia, through ADA Research Foundation. The ADA funding for Jin's lab begins this year and runs through 2010.
"I am honored and excited to receive the award because I believe it will help us to improve the understanding of how two deadly diseases are related," Jin said. "Both diabetes and heart disease have reached epidemic levels and are projected to get worse, so we appreciate Mr. Lee's generosity and applaud the ADA's support of the search for better, preventive treatments."
Diabetes Study Details
Diabetes mellitus is a long-term disease where patients lose, or see reduced, their ability to effectively process sugar consumed as food. They develop high blood sugar because the body does not produce (type 1 diabetes) or produces too little (type 2 diabetes) insulin, the enzyme that takes sugar from blood and carries it into the cells where it can be used to produce energy. Diabetes can change the chemical makeup of substances found in the blood, which can cause blood vessels to narrow or to clog completely. This process is called atherosclerosis, or hardening of the arteries, and diabetes seems to speed it up.
Jin's lab is focused on the role of oxidative stress in the development of atherosclerosis in patients with Type 2 diabetes. High blood glucose can stimulate the production of highly reactive molecules called free radicals from cells in blood and in blood vessel walls. Oxidative stress occurs when those free radicals overwhelm the antioxidant defence system in cells and cause unwanted reactions with sensitive molecules (e.g. DNA). Beyond the direct cellular damage, oxidative stress also reduces the bioavailability of nitric oxide (NO). NO signals muscle within blood vessels to relax, widening the artery and increasing blood flow. Less NO means blood vessels are less relaxed and open and more likely to clog. Derived from cells lining blood vessels (vascular endothelial cells), NO is believed to counter atherosclerosis.
High blood glucose in patients with diabetes impairs the performance of NO synthases (NOS), the enzymes that generate NO in response to blood flow, according to theory. Jin hopes to soon understand the molecular mechanisms behind this process on the way to creating new drugs that release more nitric oxide when needed to prevent cardiovascular disease in patients with diabetes.
"Diabetes is on the rise in the United States, yet the available funding for research hasn't increased at the same pace," said Don Wagner, chair of the American Diabetes Association Research Foundation. "That's why we believe it's so important to recognize and support the work of scientists like Dr. Jin, whose cutting-edge research is doing so much to improve the quality of life for people who suffer from this disease."
Contact: Greg Williams
University of Rochester Medical Center
Dia-B Believes Bark Could Help Diabetes Sufferers
Melbourne based biotechnology group Dia-B Tech Limited believes that it has found a natural alternative to anti-diabetes drug insulin in the bark of a species of vine found in rainforests of the Pacific Islands.
The chemical component produced from the vine occurs in traditional medicines but it has not been used for anti-diabetic or hypoglycaemic purposes. It is now being tested for insulin-like properties in bioassay systems, said Dia-B's Chairman Dr Michael Wooldridge.
"The medical and commercial potential this represents would be significant in the event that further research confirms that the component effectively acts as a natural 'proxy' for insulin," said Dr Wooldridge.
"This is because the synthetic insulin has debilitating effects on a number of human organs when used over a long time."
Dia-B's IM014 project is looking for a natural remedy to address type 2 diabetes and obesity.
"While this is only an indicative finding, further research is being undertaken to further identify the similarities of this component with the synthetically derived insulin used in most treatment of diabetes," Dr Wooldridge said.
In another Dia-B project, researchers at the Baker Medical Research Institute have previously identified a protein (CDA1) that offers the potential for a drug to be developed to prevent the scarring and further kidney and vascular complications caused by diabetes.
Recent breakthrough research has identified another protein found to interact with CDA1.
This is another promising approach in terms of understanding the biological roles of CDA1 and how it works, said the Baker's head of their JDRF Diabetes and Metabolism Division, Professor Mark Cooper.
"This will also provide a valuable opportunity to block CDA1's actions via interrupting the interaction between CDA1 and its important partner proteins. We will also continue to identify more proteins interacting with CDA1," Professor Cooper said.
"All of our work has strengthened the likelihood that CDA1 is an excellent target to reduce scarring, a major aim of the project."
Dia-B researchers intend to conduct further animal trials, and the Company is investigating protecting this latest discovery in research through a provisional patent application.
Further Intellectual Property, once patented, will give Dia-B a suite of Intellectual Property over the Company's diabetes research projects covering types 1 and 2 diabetes, and diabetes complications.
Dia-B Tech Limited
dia-btech.au
The chemical component produced from the vine occurs in traditional medicines but it has not been used for anti-diabetic or hypoglycaemic purposes. It is now being tested for insulin-like properties in bioassay systems, said Dia-B's Chairman Dr Michael Wooldridge.
"The medical and commercial potential this represents would be significant in the event that further research confirms that the component effectively acts as a natural 'proxy' for insulin," said Dr Wooldridge.
"This is because the synthetic insulin has debilitating effects on a number of human organs when used over a long time."
Dia-B's IM014 project is looking for a natural remedy to address type 2 diabetes and obesity.
"While this is only an indicative finding, further research is being undertaken to further identify the similarities of this component with the synthetically derived insulin used in most treatment of diabetes," Dr Wooldridge said.
In another Dia-B project, researchers at the Baker Medical Research Institute have previously identified a protein (CDA1) that offers the potential for a drug to be developed to prevent the scarring and further kidney and vascular complications caused by diabetes.
Recent breakthrough research has identified another protein found to interact with CDA1.
This is another promising approach in terms of understanding the biological roles of CDA1 and how it works, said the Baker's head of their JDRF Diabetes and Metabolism Division, Professor Mark Cooper.
"This will also provide a valuable opportunity to block CDA1's actions via interrupting the interaction between CDA1 and its important partner proteins. We will also continue to identify more proteins interacting with CDA1," Professor Cooper said.
"All of our work has strengthened the likelihood that CDA1 is an excellent target to reduce scarring, a major aim of the project."
Dia-B researchers intend to conduct further animal trials, and the Company is investigating protecting this latest discovery in research through a provisional patent application.
Further Intellectual Property, once patented, will give Dia-B a suite of Intellectual Property over the Company's diabetes research projects covering types 1 and 2 diabetes, and diabetes complications.
Dia-B Tech Limited
dia-btech.au
Peptides And Pegylated Peptides As Intranasal Permeation Enhancers: Comparison To Small Molecule Excipients
In vitro and in vivo results demonstrating the use of peptide-based
agents to enhance intranasal drug delivery of large molecules were
presented.
Formulations tested were comprised of a therapeutic
peptide and one of the following: a single permeation enhancing
peptide; a single permeation enhancing pegylated peptide; or a
combination of small molecule excipients optimized to enhance drug
permeation.
The results showed that after intranasal administration
the formulations containing a single peptide or pegylated peptide
permeation enhancer produced similar or better bioavailability of the
therapeutic peptide in the bloodstream when compared to the
formulations using multiple small molecule excipients that have
previously demonstrated enhanced bioavailability in the clinic.
The abstract is available at nastech.
Additionally, Paul Johnson, Ph.D., Chief Scientific Officer of
Nastech, participated in the AAPS Symposium, "Running Interference:
RNAi Therapeutics Enter the Clinic," discussing the challenges of
developing siRNA therapeutics to treat pandemic
influenza.
"We are pleased to share Nastech's research in discovering novel ways
to enhance intranasal drug delivery of peptides and proteins with the
outstanding group of scientists that gather annually at the
prestigious AAPS Biotechnology Conference," stated Paul Johnson,
Ph.D., Chief Scientific Officer of Nastech. "Additionally, Nastech's
participation in the symposium on siRNA therapeutics provided an
opportunity to discuss the exciting opportunities and challenges in
developing this new class of therapeutics with others in the
field."
About Nastech
Nastech is a pharmaceutical company developing innovative products
based on proprietary molecular biology-based drug delivery
technologies. Nastech and its collaboration partners are developing
products for multiple therapeutic areas including diabetes,
respiratory disease, inflammatory conditions, obesity and
osteoporosis. Additional information about Nastech is available at
nastech.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking
statements within the meaning of Federal Securities laws that are
subject to certain risks and uncertainties and involve factors that
may cause actual results to differ materially from those projected or
suggested. Factors that could cause actual results to differ
materially from those in forward-looking statements include, but are
not limited to: (i) the ability of Nastech to obtain additional
funding; (ii) the ability of Nastech to attract and/or maintain
manufacturing, research, development and commercialization partners;
(iii) Nastech's and/or a partner's ability to successfully complete
product research and development, including preclinical and clinical
studies and commercialization; (iv) Nastech's and/or a partner's
ability to obtain required governmental approvals; and (v) Nastech's
and/or a partner's ability to develop and commercialize products that
can compete favorably with those of competitors. Additional factors
that could cause actual results to differ materially from those
projected or suggested in any forward-looking statements are
contained in Nastech's most recent periodic reports on Form 10-K and
Form 10-Q that are filed with the Securities and Exchange Commission.
Nastech assumes no obligation to update and supplement forward-
looking statements because of subsequent events.
nastech
agents to enhance intranasal drug delivery of large molecules were
presented.
Formulations tested were comprised of a therapeutic
peptide and one of the following: a single permeation enhancing
peptide; a single permeation enhancing pegylated peptide; or a
combination of small molecule excipients optimized to enhance drug
permeation.
The results showed that after intranasal administration
the formulations containing a single peptide or pegylated peptide
permeation enhancer produced similar or better bioavailability of the
therapeutic peptide in the bloodstream when compared to the
formulations using multiple small molecule excipients that have
previously demonstrated enhanced bioavailability in the clinic.
The abstract is available at nastech.
Additionally, Paul Johnson, Ph.D., Chief Scientific Officer of
Nastech, participated in the AAPS Symposium, "Running Interference:
RNAi Therapeutics Enter the Clinic," discussing the challenges of
developing siRNA therapeutics to treat pandemic
influenza.
"We are pleased to share Nastech's research in discovering novel ways
to enhance intranasal drug delivery of peptides and proteins with the
outstanding group of scientists that gather annually at the
prestigious AAPS Biotechnology Conference," stated Paul Johnson,
Ph.D., Chief Scientific Officer of Nastech. "Additionally, Nastech's
participation in the symposium on siRNA therapeutics provided an
opportunity to discuss the exciting opportunities and challenges in
developing this new class of therapeutics with others in the
field."
About Nastech
Nastech is a pharmaceutical company developing innovative products
based on proprietary molecular biology-based drug delivery
technologies. Nastech and its collaboration partners are developing
products for multiple therapeutic areas including diabetes,
respiratory disease, inflammatory conditions, obesity and
osteoporosis. Additional information about Nastech is available at
nastech.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking
statements within the meaning of Federal Securities laws that are
subject to certain risks and uncertainties and involve factors that
may cause actual results to differ materially from those projected or
suggested. Factors that could cause actual results to differ
materially from those in forward-looking statements include, but are
not limited to: (i) the ability of Nastech to obtain additional
funding; (ii) the ability of Nastech to attract and/or maintain
manufacturing, research, development and commercialization partners;
(iii) Nastech's and/or a partner's ability to successfully complete
product research and development, including preclinical and clinical
studies and commercialization; (iv) Nastech's and/or a partner's
ability to obtain required governmental approvals; and (v) Nastech's
and/or a partner's ability to develop and commercialize products that
can compete favorably with those of competitors. Additional factors
that could cause actual results to differ materially from those
projected or suggested in any forward-looking statements are
contained in Nastech's most recent periodic reports on Form 10-K and
Form 10-Q that are filed with the Securities and Exchange Commission.
Nastech assumes no obligation to update and supplement forward-
looking statements because of subsequent events.
nastech
Sirtris Announces SRT501 Lowers Glucose In Twice-Daily Dosing Clinical Trial
Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced positive top-line data from its twice-daily dosing study of SRT501, the company's proprietary formulation of resveratrol. The Phase 1b clinical trial, which tested either 1.25 or 2.5 grams of SRT501 given twice daily to Type 2 Diabetic patients, found that the patient group receiving 2.5 grams twice a day had significantly lower blood glucose levels as determined through an oral glucose tolerance test (OGTT) at the test's two-hour time point, as compared with the placebo group.
At 2.5 grams twice daily, the study also found that SRT501 had a statistically significant lowering of both fasting blood glucose and glucose levels after meals, known as the postprandial period, an important timeframe for Type 2 Diabetics who need better control of blood sugar levels after eating. While not at the level of statistical significance, this dose level also showed a strong trend in lowering postprandial insulin levels.
At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.
The company plans to present the full data at the American Diabetes Association annual meeting in June.
"With this study, and the Phase 1b once daily dosing study data that we announced in January of this year, we have now observed a lowering of glucose in Type 2 Diabetic patients in two clinical trials with SRT501," says Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris. "The two Phase 1b clinical trials tested SRT501 at different dosage levels and dose time points. While the primary focus of each study was safety and blood levels of SRT501, by developing the studies as we did, we are also able to see signs of efficacy and dose response."
"Our clinical trial program with SRT501 further validates our approach in targeting the SIRT1 enzyme for the development of a potential new treatment for Type 2 Diabetes," says Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris. "Today's Phase 1b announcement is the second time we've seen a translation of the positive results from preclinical studies carry over to humans."
The current multi-center, blinded and randomized Phase 1b study included approximately 100 Type 2 Diabetic patients divided into three groups. The first patient group received 1.25 grams of SRT501 twice daily for a total daily-dose level of 2.5 grams. The second patient group received 2.5 grams twice daily for a total daily-dose level of 5.0 grams. The third group received placebo twice daily.
The study was designed to assess the safety, tolerability and pharmacokinetics of twice-daily, orally administered dosing of SRT501 at 2.5 and 5.0 total grams. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study also indicates that suitable pharmacokinetics, a measure of drug levels in the blood, was achieved.
In January of this year, Sirtris announced positive Phase 1b trial results of its once-daily dosing of SRT501 at 2.5 and 5.0 grams. In that study, SRT501 was also found to be safe and well-tolerated and to significantly lower glucose as compared to the placebo group in an OGTT at the two-hour time point as part of the 28 day trial of patients with Type 2 Diabetes.
SRT501 is currently being tested in patients with Type 2 Diabetes in a Phase 2a study in combination with metformin, the current first-line therapy for Type 2 Diabetes. Results from this trial are expected in the second-half of this year.
Sirtris has also identified new chemical entities (NCEs) that are chemically distinct from resveratrol, and in in-vitro tests are up to 1,000 times more potent. In preclinical models of Type 2 Diabetes, Sirtris' NCEs have lowered glucose and improved sensitivity.
About Sirtris Pharmaceuticals
Sirtris Pharmaceuticals is a biopharmaceutical company focused on discovering and developing proprietary, orally available, small molecule drugs with the potential to treat diseases associated with aging, including metabolic diseases, such as Type 2 Diabetes. Our drug candidates are designed to mimic certain beneficial health effects of calorie restriction, without requiring a change in eating habits, by activation of sirtuins, a recently discovered class of enzymes that control the aging process. The company's headquarters are in Cambridge, Massachusetts.
sirtrispharma
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the potential therapeutic effects of SIRT1 activators including SRT501 for diseases of aging, such as Type 2 Diabetes, the progress and results of pre-clinical and clinical studies of SIRT1 activators, the potential therapeutic effects of SRT501 and other SIRT1 activators, and the potential of sirtuin modulators and activators to receive regulatory approval. These forward-looking statements about future expectations, plans and prospects of Sirtris Pharmaceuticals involve significant risks, uncertainties and assumptions, including risks related to the lack of results that would provide a basis for predicting whether any of the Company's product candidates will be safe or effective, or receive regulatory approval, the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results, the Company's potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates, the fact that none of the Company's product candidates has received regulatory approvals, the potential inability of the Company to gain market acceptance of the Company's product candidates, and those other risks factors that can be found in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from those Sirtris Pharmaceuticals contemplated by these forward-looking statements. Sirtris Pharmaceuticals does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.
Sirtris Pharmaceuticals
At 2.5 grams twice daily, the study also found that SRT501 had a statistically significant lowering of both fasting blood glucose and glucose levels after meals, known as the postprandial period, an important timeframe for Type 2 Diabetics who need better control of blood sugar levels after eating. While not at the level of statistical significance, this dose level also showed a strong trend in lowering postprandial insulin levels.
At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.
The company plans to present the full data at the American Diabetes Association annual meeting in June.
"With this study, and the Phase 1b once daily dosing study data that we announced in January of this year, we have now observed a lowering of glucose in Type 2 Diabetic patients in two clinical trials with SRT501," says Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris. "The two Phase 1b clinical trials tested SRT501 at different dosage levels and dose time points. While the primary focus of each study was safety and blood levels of SRT501, by developing the studies as we did, we are also able to see signs of efficacy and dose response."
"Our clinical trial program with SRT501 further validates our approach in targeting the SIRT1 enzyme for the development of a potential new treatment for Type 2 Diabetes," says Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris. "Today's Phase 1b announcement is the second time we've seen a translation of the positive results from preclinical studies carry over to humans."
The current multi-center, blinded and randomized Phase 1b study included approximately 100 Type 2 Diabetic patients divided into three groups. The first patient group received 1.25 grams of SRT501 twice daily for a total daily-dose level of 2.5 grams. The second patient group received 2.5 grams twice daily for a total daily-dose level of 5.0 grams. The third group received placebo twice daily.
The study was designed to assess the safety, tolerability and pharmacokinetics of twice-daily, orally administered dosing of SRT501 at 2.5 and 5.0 total grams. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study also indicates that suitable pharmacokinetics, a measure of drug levels in the blood, was achieved.
In January of this year, Sirtris announced positive Phase 1b trial results of its once-daily dosing of SRT501 at 2.5 and 5.0 grams. In that study, SRT501 was also found to be safe and well-tolerated and to significantly lower glucose as compared to the placebo group in an OGTT at the two-hour time point as part of the 28 day trial of patients with Type 2 Diabetes.
SRT501 is currently being tested in patients with Type 2 Diabetes in a Phase 2a study in combination with metformin, the current first-line therapy for Type 2 Diabetes. Results from this trial are expected in the second-half of this year.
Sirtris has also identified new chemical entities (NCEs) that are chemically distinct from resveratrol, and in in-vitro tests are up to 1,000 times more potent. In preclinical models of Type 2 Diabetes, Sirtris' NCEs have lowered glucose and improved sensitivity.
About Sirtris Pharmaceuticals
Sirtris Pharmaceuticals is a biopharmaceutical company focused on discovering and developing proprietary, orally available, small molecule drugs with the potential to treat diseases associated with aging, including metabolic diseases, such as Type 2 Diabetes. Our drug candidates are designed to mimic certain beneficial health effects of calorie restriction, without requiring a change in eating habits, by activation of sirtuins, a recently discovered class of enzymes that control the aging process. The company's headquarters are in Cambridge, Massachusetts.
sirtrispharma
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the potential therapeutic effects of SIRT1 activators including SRT501 for diseases of aging, such as Type 2 Diabetes, the progress and results of pre-clinical and clinical studies of SIRT1 activators, the potential therapeutic effects of SRT501 and other SIRT1 activators, and the potential of sirtuin modulators and activators to receive regulatory approval. These forward-looking statements about future expectations, plans and prospects of Sirtris Pharmaceuticals involve significant risks, uncertainties and assumptions, including risks related to the lack of results that would provide a basis for predicting whether any of the Company's product candidates will be safe or effective, or receive regulatory approval, the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results, the Company's potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates, the fact that none of the Company's product candidates has received regulatory approvals, the potential inability of the Company to gain market acceptance of the Company's product candidates, and those other risks factors that can be found in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from those Sirtris Pharmaceuticals contemplated by these forward-looking statements. Sirtris Pharmaceuticals does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.
Sirtris Pharmaceuticals
Type 1 Diabetes In Adults Better Controlled With Continuous Monitors
A study by a diabetes research foundation discovered that adults with type 1 diabetes were better at controlling their glucose levels when instead
of the traditional method of pricking a finger a few times a day, they used continuous monitors that sampled blood every five minutes through a small
tube under the skin and alerted them so they could adjust their eating or take insulin more promptly.
The study was carried out by the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group and is being presented this
week at the 44th European Association for the Study of Diabetes annual meeting in Rome. The results are also published in the 8th September
online issue of the New England Journal of Medicine, NEJM.
The researchers tested 3 devices made by Abbott Laboratories, Medtronic and DexCom Inc. The results showed that adults with type 1 diabetes
who used the devices consistently kept their blood glucose levels within the desired limits.
The research was done because nobody had yet evaluated the benefit of continuous monitoring in the management of type 1 diabetes
mellitus.
Type 1 diabetes is an autoimmune disease that destroys insulin producing cells in the pancreas. Control of blood sugar in diabetes reduces the risk
of blindness (diabetic retinopathy), kidney failure, heart disease and amputation.
For the study, the researchers randomly assigned 322 adults and children participating in a multicenter clinical trial and who were already being
treated for type 1 diabetes to two groups. One group was fitted with continuous monitoring devices and the other group, the control group, continued
to manage their blood glucose with a home monitor as normal (the traditional "finger pricking" method).
The main measurement point was the change in blood glucose after 26 weeks. When they started, all patients had blood glucose (a1c or glycated
hemoglobin) levels ranging from 7 to 10 per cent.
The results showed that:
The changes in blood glucose level in the two groups changed significantly according to age group.
There was a significant difference among those aged 25 and over that favoured the group using the continuous monitors.
For the age bands 15 to 25, and 8 to 14, there was no significant difference between the continuous monitor and the conventional monitor
groups.
For the oldest (25 and over) and youngest patients (8 to 14) secondary glycated hemoglobin outcomes were better in the continuous monitoring
group than in the control group, but this was not the case for the 15 to 24 year olds.
A secondary analysis of the oldest age band (25 and over) showed that more patients using continuous monitors had a relative reduction of 10
per cent or more in the mean glycated hemoglobin level, as compared with baseline.
More of the oldest age band (25 and over) patients in the continuous monitoring group also achieved a blood sugar level of below 7 per cent, as
recommended for adults by the American Diabetes Association.
83 per cent of the patients in the oldest age band (25 and over) used continuous glucose monitoring for an average of 6.0 or more days a
week.
This was only 30 per cent for the 15 to 24 year olds and 50 per cent for the 8 to 14 year olds.
The researchers concluded that:
"Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes."
As far as younger patients were concerned, they concluded that:
"Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents."
Dr Aaron Kowalski of the Juvenile Diabetes Research Foundation, which funded and carried out the study, told reporters in a telephone interview
reported by Reuters:
"These results are very important because they show that continuous glucose monitors are more than simply devices of convenience for people with
diabetes -- they are tools that can substantially improve blood sugar control when used regularly."
"Every 10 percent you lower your a1c [glycated hemoglobin] is about a 40 percent reduction in the risk of diabetic retinopathy," said
Kowalski.
According to the Juvenile Diabetes Research Foundation there are about 3 million Americans living with type 1 diabetes.
"Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes."
The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group.
NEJM, Published online September 8, 2008.
DOI: 10.1056/NEJMoa0805017.
Click here for
Abstract.
of the traditional method of pricking a finger a few times a day, they used continuous monitors that sampled blood every five minutes through a small
tube under the skin and alerted them so they could adjust their eating or take insulin more promptly.
The study was carried out by the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group and is being presented this
week at the 44th European Association for the Study of Diabetes annual meeting in Rome. The results are also published in the 8th September
online issue of the New England Journal of Medicine, NEJM.
The researchers tested 3 devices made by Abbott Laboratories, Medtronic and DexCom Inc. The results showed that adults with type 1 diabetes
who used the devices consistently kept their blood glucose levels within the desired limits.
The research was done because nobody had yet evaluated the benefit of continuous monitoring in the management of type 1 diabetes
mellitus.
Type 1 diabetes is an autoimmune disease that destroys insulin producing cells in the pancreas. Control of blood sugar in diabetes reduces the risk
of blindness (diabetic retinopathy), kidney failure, heart disease and amputation.
For the study, the researchers randomly assigned 322 adults and children participating in a multicenter clinical trial and who were already being
treated for type 1 diabetes to two groups. One group was fitted with continuous monitoring devices and the other group, the control group, continued
to manage their blood glucose with a home monitor as normal (the traditional "finger pricking" method).
The main measurement point was the change in blood glucose after 26 weeks. When they started, all patients had blood glucose (a1c or glycated
hemoglobin) levels ranging from 7 to 10 per cent.
The results showed that:
The changes in blood glucose level in the two groups changed significantly according to age group.
There was a significant difference among those aged 25 and over that favoured the group using the continuous monitors.
For the age bands 15 to 25, and 8 to 14, there was no significant difference between the continuous monitor and the conventional monitor
groups.
For the oldest (25 and over) and youngest patients (8 to 14) secondary glycated hemoglobin outcomes were better in the continuous monitoring
group than in the control group, but this was not the case for the 15 to 24 year olds.
A secondary analysis of the oldest age band (25 and over) showed that more patients using continuous monitors had a relative reduction of 10
per cent or more in the mean glycated hemoglobin level, as compared with baseline.
More of the oldest age band (25 and over) patients in the continuous monitoring group also achieved a blood sugar level of below 7 per cent, as
recommended for adults by the American Diabetes Association.
83 per cent of the patients in the oldest age band (25 and over) used continuous glucose monitoring for an average of 6.0 or more days a
week.
This was only 30 per cent for the 15 to 24 year olds and 50 per cent for the 8 to 14 year olds.
The researchers concluded that:
"Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes."
As far as younger patients were concerned, they concluded that:
"Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents."
Dr Aaron Kowalski of the Juvenile Diabetes Research Foundation, which funded and carried out the study, told reporters in a telephone interview
reported by Reuters:
"These results are very important because they show that continuous glucose monitors are more than simply devices of convenience for people with
diabetes -- they are tools that can substantially improve blood sugar control when used regularly."
"Every 10 percent you lower your a1c [glycated hemoglobin] is about a 40 percent reduction in the risk of diabetic retinopathy," said
Kowalski.
According to the Juvenile Diabetes Research Foundation there are about 3 million Americans living with type 1 diabetes.
"Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes."
The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group.
NEJM, Published online September 8, 2008.
DOI: 10.1056/NEJMoa0805017.
Click here for
Abstract.
NHS Diabetes Management Targets Need To Address Inequalities, UK
Large variations in the quality of diabetes management exist between general practices in London with younger people worse off, according to a new study published in the Journal of the Royal Society of Medicine.
These are the findings of a survey of over 6000 patient records in 34 GP practices in south London. The study conducted by Christopher Millett and colleagues at Imperial College found that younger patients with diabetes had poorer recording of quality care and were more likely to suffer from higher cholesterol and poorer glycaemic control than older patients.
"We found considerable variation in the quality of diabetes care between GP practices in London, with younger patients aged 18 to 44 receiving poorer care," said Mr Millett.
"There is scope to improve the management of diabetes in most patients. However, our findings suggest that we need to raise awareness amongst GPs about the importance of closely monitoring diabetes control in younger patients.
"Failure to improve diabetes management amongst these patients may lead to an increase in major complications of the condition, such as heart disease, in future years," he said.
"Additional research is required to determine whether government initiatives to improve the quality of diabetes care, such as the National Service Framework and new GP contract, have been successful in reducing the variations in management identified in this study," Mr Millett said.
More than two million people in the UK are known to have diabetes with a further one million estimated to have the disease but not know it.
Diabetes has been identified as a national priority condition with considerable investment made in recent years to improve the quality of care received by patients. This includes the National Service Framework for Diabetes published in 2001 and the new General Practitioner contract in 2004.
'Association of age, sex and deprivation with quality indicators for diabetes: population-based cross sectional survey in primary care' by J Gray, C Millett, C O'Sullivan, RZ Omar & A Majeed is published in the November 2006 issue of the Journal of the Royal Society of Medicine.
JRSM is the flagship journal of the Royal Society of Medicine. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi.
The article is available free at rsm.ac.uk
Contact:
Rania Wannous, The Royal Society of Medicine
Founded in 1805, the Royal Society of Medicine is an independent organisation that promotes the exchange of knowledge, information and ideas in medical science and continued improvement in human health.
Registered Charity No. 206219
For further information please visit:
Royal Society of Medicine
These are the findings of a survey of over 6000 patient records in 34 GP practices in south London. The study conducted by Christopher Millett and colleagues at Imperial College found that younger patients with diabetes had poorer recording of quality care and were more likely to suffer from higher cholesterol and poorer glycaemic control than older patients.
"We found considerable variation in the quality of diabetes care between GP practices in London, with younger patients aged 18 to 44 receiving poorer care," said Mr Millett.
"There is scope to improve the management of diabetes in most patients. However, our findings suggest that we need to raise awareness amongst GPs about the importance of closely monitoring diabetes control in younger patients.
"Failure to improve diabetes management amongst these patients may lead to an increase in major complications of the condition, such as heart disease, in future years," he said.
"Additional research is required to determine whether government initiatives to improve the quality of diabetes care, such as the National Service Framework and new GP contract, have been successful in reducing the variations in management identified in this study," Mr Millett said.
More than two million people in the UK are known to have diabetes with a further one million estimated to have the disease but not know it.
Diabetes has been identified as a national priority condition with considerable investment made in recent years to improve the quality of care received by patients. This includes the National Service Framework for Diabetes published in 2001 and the new General Practitioner contract in 2004.
'Association of age, sex and deprivation with quality indicators for diabetes: population-based cross sectional survey in primary care' by J Gray, C Millett, C O'Sullivan, RZ Omar & A Majeed is published in the November 2006 issue of the Journal of the Royal Society of Medicine.
JRSM is the flagship journal of the Royal Society of Medicine. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi.
The article is available free at rsm.ac.uk
Contact:
Rania Wannous, The Royal Society of Medicine
Founded in 1805, the Royal Society of Medicine is an independent organisation that promotes the exchange of knowledge, information and ideas in medical science and continued improvement in human health.
Registered Charity No. 206219
For further information please visit:
Royal Society of Medicine
Diabetes Type 1 Vaccine - Diamyd(R) Phase III Study Approved By Six European Countries
Today Diamyd Medical (Pink Sheets:DMYDY)(STO:DIAMB) reported that six European countries have approved the initiation of a Phase III study with the Diamyd® diabetes vaccine for type 1 diabetes.
The application processes to the national regulatory agencies and ethics committees have proceeded according to plan, and the company has now received agency approvals for a European Phase III study of children and adolescents with type 1 diabetes in the Netherlands, United Kingdom, Finland, Slovenia, Spain and Sweden.
"We are delighted to report this good news to the market today," says Elisabeth Lindner, President and CEO of Diamyd Medical. "The fact that Diamyd successfully pursues a project as large as its Phase III program on its own with limited resources demonstrates that we have an extremely competent and committed organization. The different cultures, languages, regulations and regulatory procedures for different countries demand a lot from the applying company. We have met all of this year's intermediate goals on time, and we are continuing our strategy of building a market-oriented pharmaceutical company in the area of diabetes." Diamyd Medical is conducting two clinical Phase III studies with the Diamyd® diabetes vaccine for type 1 diabetes, one in Europe and the other in the US. The studies apply to people recently diagnosed with type 1 diabetes, i.e. within the last three months.
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company's most advanced project is the GAD-based drug Diamyd® for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS). The company has also out-licensed the use of GAD for the treatment of Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available on the company's web site: diamyd
This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.
Diamyd Medical
The application processes to the national regulatory agencies and ethics committees have proceeded according to plan, and the company has now received agency approvals for a European Phase III study of children and adolescents with type 1 diabetes in the Netherlands, United Kingdom, Finland, Slovenia, Spain and Sweden.
"We are delighted to report this good news to the market today," says Elisabeth Lindner, President and CEO of Diamyd Medical. "The fact that Diamyd successfully pursues a project as large as its Phase III program on its own with limited resources demonstrates that we have an extremely competent and committed organization. The different cultures, languages, regulations and regulatory procedures for different countries demand a lot from the applying company. We have met all of this year's intermediate goals on time, and we are continuing our strategy of building a market-oriented pharmaceutical company in the area of diabetes." Diamyd Medical is conducting two clinical Phase III studies with the Diamyd® diabetes vaccine for type 1 diabetes, one in Europe and the other in the US. The studies apply to people recently diagnosed with type 1 diabetes, i.e. within the last three months.
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company's most advanced project is the GAD-based drug Diamyd® for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS). The company has also out-licensed the use of GAD for the treatment of Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available on the company's web site: diamyd
This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.
Diamyd Medical
Epigenomics Discovery Yields New Information About Fat Cells
By creating a "map" of histone modifications in fat cells, investigators have discovered two new factors that regulate fat formation, a key step on the road to better understanding obesity, diabetes and other metabolic disorders. Led by investigators at Beth Israel Deaconess Medical Center (BIDMC) and the Broad Institute, the study appears in the October 1 issue of the journal Cell.
"These findings help to demonstrate the power of epigenomic mapping when it comes to gleaning key insights into fat cell formation," explains senior author Evan Rosen, MD, PhD, an investigator in the Department of Endocrinology, Diabetes and Metabolism at BIDMC and Associate Professor of Medicine at Harvard Medical School. Fat cells, also called adipocytes, play an integral role in regulating metabolism by controlling lipid and glucose balance.
To better understand how adipocytes control the genes that impart the specialized functions of these cells, the researchers turned to epigenomics, and specifically the arm of epigenomics known as histone modifications.
"Deoxyribonucleic acid [DNA] is tightly wound around proteins called histones, which, over time, can accumulate chemical modifications or 'marks,'" explains Rosen. "These marks instruct the cell which genes to turn on and off, and by mapping these modifications, we can gain important insights that would be unattainable through traditional means."
Unlike previous investigations, which examined fat cells at a single static time point, this new study mapped several histone modifications throughout the course of the fat cell development, using a technique called chromatin immunoprecipitation followed by massively parallel sequencing or ChIP-Seq. This method relies on the ability to sequence tens of millions of short stretches of DNA (in this case DNA bound to modified histones) and then to reassemble results into a coherent genome. In addition to following these histone markers across time, the scientists also mapped the markers across species.
"Our study looked at both mouse cells and human cells," explains Rosen. "This is key because each cell type can accumulate histone marks that actually have nothing to do with fat cell differentiation. Consequently, by comparing two different cell models, we were able to sift through and focus on the epigenetic marks that appeared in both cell types."
What emerged was a "core" set of histone modifications that formed the basis of a "road map" for the scientists to follow. And, by using this new map, the investigators discovered two transcription factors (proteins that control the copying of DNA into RNA) that regulate fat cell formation.
"We found two new transcription factors - SRF and PLZF - involved in fat cell development," explains Rosen. "We have essentially demonstrated how an epigenomic 'road map' can be used to identify biology that could not have been predicted through any other means." Subsequent experiments confirmed the proteins' roles in fat cell development: When either the SRF or the PLZF protein was decreased, fat cells generated at a faster rate and, conversely, when the amount of either protein was increased, fat cell development ceased.
"Although these particular studies were focused on the development of fat cells, we have reason to think that SRF and PLZF may be involved in the workings of mature fat cells as well," notes Rosen, adding that these new findings, therefore, have the potential to impact metabolic diseases such as obesity and Type 2 diabetes.
"The huge costs of obesity and metabolic disease, both in terms of health and from a financial standpoint, are making adipocyte biology increasingly important," he adds. "With these new findings we now have a better understanding of normal fat cell development, and going forward, we can compare normal fat cells to fat cells in disease states. If we can better understand why fat cells behave as they do, then we can work to develop therapies for obesity or diabetes."
Notes:
This study was funded by grants from the National Institutes of Health and the American Diabetes Association.
Co-first authors of the study are Zhao Xu of BIDMC and Tarjei Mikkelsen of the Broad Institute. Coauthors include Broad Institute investigators Xiaolan Zhang, Li Wang and Eric Lander; and Jeffrey Gimble of the Pennington Biomedical Research Center, Louisiana University System.
"These findings help to demonstrate the power of epigenomic mapping when it comes to gleaning key insights into fat cell formation," explains senior author Evan Rosen, MD, PhD, an investigator in the Department of Endocrinology, Diabetes and Metabolism at BIDMC and Associate Professor of Medicine at Harvard Medical School. Fat cells, also called adipocytes, play an integral role in regulating metabolism by controlling lipid and glucose balance.
To better understand how adipocytes control the genes that impart the specialized functions of these cells, the researchers turned to epigenomics, and specifically the arm of epigenomics known as histone modifications.
"Deoxyribonucleic acid [DNA] is tightly wound around proteins called histones, which, over time, can accumulate chemical modifications or 'marks,'" explains Rosen. "These marks instruct the cell which genes to turn on and off, and by mapping these modifications, we can gain important insights that would be unattainable through traditional means."
Unlike previous investigations, which examined fat cells at a single static time point, this new study mapped several histone modifications throughout the course of the fat cell development, using a technique called chromatin immunoprecipitation followed by massively parallel sequencing or ChIP-Seq. This method relies on the ability to sequence tens of millions of short stretches of DNA (in this case DNA bound to modified histones) and then to reassemble results into a coherent genome. In addition to following these histone markers across time, the scientists also mapped the markers across species.
"Our study looked at both mouse cells and human cells," explains Rosen. "This is key because each cell type can accumulate histone marks that actually have nothing to do with fat cell differentiation. Consequently, by comparing two different cell models, we were able to sift through and focus on the epigenetic marks that appeared in both cell types."
What emerged was a "core" set of histone modifications that formed the basis of a "road map" for the scientists to follow. And, by using this new map, the investigators discovered two transcription factors (proteins that control the copying of DNA into RNA) that regulate fat cell formation.
"We found two new transcription factors - SRF and PLZF - involved in fat cell development," explains Rosen. "We have essentially demonstrated how an epigenomic 'road map' can be used to identify biology that could not have been predicted through any other means." Subsequent experiments confirmed the proteins' roles in fat cell development: When either the SRF or the PLZF protein was decreased, fat cells generated at a faster rate and, conversely, when the amount of either protein was increased, fat cell development ceased.
"Although these particular studies were focused on the development of fat cells, we have reason to think that SRF and PLZF may be involved in the workings of mature fat cells as well," notes Rosen, adding that these new findings, therefore, have the potential to impact metabolic diseases such as obesity and Type 2 diabetes.
"The huge costs of obesity and metabolic disease, both in terms of health and from a financial standpoint, are making adipocyte biology increasingly important," he adds. "With these new findings we now have a better understanding of normal fat cell development, and going forward, we can compare normal fat cells to fat cells in disease states. If we can better understand why fat cells behave as they do, then we can work to develop therapies for obesity or diabetes."
Notes:
This study was funded by grants from the National Institutes of Health and the American Diabetes Association.
Co-first authors of the study are Zhao Xu of BIDMC and Tarjei Mikkelsen of the Broad Institute. Coauthors include Broad Institute investigators Xiaolan Zhang, Li Wang and Eric Lander; and Jeffrey Gimble of the Pennington Biomedical Research Center, Louisiana University System.
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