From the American Medical News, Sept. 27, 2004:
By Victoria Stagg Elliott, AMNews staff
Type 1 diabetes, often viewed as inevitable for those predisposed to it, could one day be as preventable as its well-known relative, type 2.
Such a shift in understanding would be revolutionary. It also would create a need for primary care physicians to take on screening and prevention for type 1 with the same vigor as they currently do for type 2.
For now, though, prevention of type 1 is a proposition of someday, spoken of in terms of "if," not "when." Even so, many experts believe that they now possess important clues that will help them solve the mystery of how to stop it before it starts.
To that end, the National Institute of Diabetes and Digestive and Kidney Diseases in June launched TrialNet, an international network of 18 centers that will study interventions that may prevent development of the disease and improve the prospects for those newly diagnosed with it.
"This will absolutely be in the purview of primary care physicians once we have something that we really think delays or prevents diabetes," said Ellen Leschek, MD, TrialNet's program director. "Even if you're talking about delaying by just two or three years, that's substantial, because every moment that you have diabetes, those are moments that are contributing towards having the long-term effects."
The network is building on the work of the Diabetes Prevention Trial-Type 1, also funded by NIDDK and launched in 1995, which examined the use of low doses of injectable insulin or oral insulin to prevent the development of the disease in those at high risk.
The results, published in the New England Journal of Medicine May 30, 2002, clearly showed that neither intervention worked. In the process, however, researchers learned how to predict who was most likely to progress to type 1 diabetes.
"We can now identify who's at risk for diabetes. It's just a matter of time before we find agents that will actually prevent diabetes," said H. Peter Chase, MD, one of TrialNet's principal investigators and a professor of pediatrics at the University of Colorado Health Sciences Center.
Being able to make this determination allows researchers to target interventions to those who would benefit the most. This testing is also most likely to be the first innovation out of the initial trial and TrialNet to make inroads into clinical practice -- although not just yet.
Sunday, October 10, 2004
Saturday, October 09, 2004
NIH to Award $75M to Study Islet Transplantation
Press Release: Oct. 4, 2004
NIH Funds Centers to Study Islet Transplantation
The National Institutes of Health (NIH) announced today that it plans to award about $75 million over five years to five clinical centers and a data coordinating center to conduct studies of islet transplantation in patients with type 1 diabetes. The network includes centers located in Iowa City, Miami, Minneapolis and Philadelphia, as well as in Edmonton, Canada, and Uppsala, Sweden.
The studies will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes. Some studies will focus on improving combined islet and kidney transplants in patients with type 1 diabetes and kidney failure, a common complication of diabetes.
“This award accelerates studies of an experimental approach that could be very promising for some people with severe type 1 diabetes if specific barriers can be overcome,” said Dr. Thomas Eggerman, who oversees the consortium for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Two institutes of the National Institutes of Health (NIH) — the NIDDK and the National Institute of Allergy and Infectious Diseases (NIAID) — sponsor the consortium.
Type 1 diabetes accounts for up to 10 percent of diagnosed cases of diabetes in the United States (up to 1 million people). This form of diabetes usually strikes children and young adults, who need several insulin injections a day or an insulin pump to survive. Insulin, though critical for controlling blood glucose, is no cure. Most people with type 1 diabetes eventually develop one or more complications, including damage to the heart and blood vessels, eyes, nerves, and kidneys.
In islet transplantation, islets are extracted from the pancreas of a deceased donor and infused into a person with difficult-to-control type 1 diabetes though the portal vein of the liver. In successful transplants, the cells lodge in the liver’s small blood vessels and begin producing insulin.
In the 1990’s, islet transplantation rarely succeeded in freeing patients from insulin injections for more than a year. In June 2000, however, a research team led by Dr. James Shapiro at the University of Alberta in Edmonton, Canada, reported sustained insulin independence in seven patients transplanted with islets from two to four donor pancreases. The patients received an immunosuppressive regimen that omitted glucocorticoids, also known as steroids, which were often used to prevent rejection but are now thought to be toxic to islets. In the next few years, researchers participating in the Immune Tolerance Network (ITN), a collaboration of clinical and basic researchers sponsored by the NIAID, NIDDK, and the Juvenile Diabetes Research Foundation International, replicated what became known as the “Edmonton protocol.”
Despite these gains, scientists continue to grapple with several impediments to the wider testing of islet transplantation. One is the scarcity of islets. Only about 6,000 donor pancreases become available each year, and many are used for whole organ transplantation. Posing another obstacle are the potentially serious side effects — such as anemia, nerve damage, meningitis, and vulnerability to infection — of the medications that stop the immune system from rejecting donor islets. Finally, in some transplanted patients, donor islets function well initially, but in time diabetes recurs. Why the islets die is not well understood.
Recent NIH-funded advances may lead to some answers. “Newly developed immune assays are helping us flesh out a more complete picture of the immune events that trigger rejection,” said Dr. Nancy Bridges, who oversees the consortium for NIAID. “Studies are also laying the groundwork for less toxic immunosuppressive agents, which will be tested in upcoming trials. Our ultimate goal is to develop ways to induce tolerance, a state of immune acceptance of the donor tissue or organ.”
Researchers in the newly funded centers will be designing studies to:
* improve the isolation and viability of islets
* reduce complications of the transplant procedure, e.g., bleeding and clotting
* reduce the side effects of immunosuppression
* trace the fate of islets after transplantation and determine why donor islets sometimes fail
* evaluate new ways to safely prevent immune rejection of donor tissues.
Newly designed studies will be submitted for review by the Food and Drug Administration, the NIDDK/NIAID Islet Transplantation Data and Safety Monitoring Board, and local institutional review boards before being offered to patients. Patient enrollment is scheduled to begin in 2005.
The consortium consists of the following principal investigators and centers:
Dr. William Clarke, University of Iowa (Data Coordinating Center)
Iowa City, Iowa
Dr. Camillo Ricordi, University of Miami
Miami, Florida
Dr. Bernhard Hering, University of Minnesota
Minneapolis, Minnesota
Dr. Ali Naji, University of Pennsylvania
Philadelphia, Pennsylvania
Dr. James Shapiro, University of Alberta
Edmonton, Alberta, Canada
Dr. Olle Korsgren, Uppsala University
Uppsala, Sweden
The consortium is supported by a special funding program for type 1 diabetes research, which provides a total of $1.14 billion from fiscal year 1998 through fiscal year 2008 to supplement other funds for type 1 diabetes research made available through the regular NIH appropriations process.
NIH Funds Centers to Study Islet Transplantation
The National Institutes of Health (NIH) announced today that it plans to award about $75 million over five years to five clinical centers and a data coordinating center to conduct studies of islet transplantation in patients with type 1 diabetes. The network includes centers located in Iowa City, Miami, Minneapolis and Philadelphia, as well as in Edmonton, Canada, and Uppsala, Sweden.
The studies will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes. Some studies will focus on improving combined islet and kidney transplants in patients with type 1 diabetes and kidney failure, a common complication of diabetes.
“This award accelerates studies of an experimental approach that could be very promising for some people with severe type 1 diabetes if specific barriers can be overcome,” said Dr. Thomas Eggerman, who oversees the consortium for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Two institutes of the National Institutes of Health (NIH) — the NIDDK and the National Institute of Allergy and Infectious Diseases (NIAID) — sponsor the consortium.
Type 1 diabetes accounts for up to 10 percent of diagnosed cases of diabetes in the United States (up to 1 million people). This form of diabetes usually strikes children and young adults, who need several insulin injections a day or an insulin pump to survive. Insulin, though critical for controlling blood glucose, is no cure. Most people with type 1 diabetes eventually develop one or more complications, including damage to the heart and blood vessels, eyes, nerves, and kidneys.
In islet transplantation, islets are extracted from the pancreas of a deceased donor and infused into a person with difficult-to-control type 1 diabetes though the portal vein of the liver. In successful transplants, the cells lodge in the liver’s small blood vessels and begin producing insulin.
In the 1990’s, islet transplantation rarely succeeded in freeing patients from insulin injections for more than a year. In June 2000, however, a research team led by Dr. James Shapiro at the University of Alberta in Edmonton, Canada, reported sustained insulin independence in seven patients transplanted with islets from two to four donor pancreases. The patients received an immunosuppressive regimen that omitted glucocorticoids, also known as steroids, which were often used to prevent rejection but are now thought to be toxic to islets. In the next few years, researchers participating in the Immune Tolerance Network (ITN), a collaboration of clinical and basic researchers sponsored by the NIAID, NIDDK, and the Juvenile Diabetes Research Foundation International, replicated what became known as the “Edmonton protocol.”
Despite these gains, scientists continue to grapple with several impediments to the wider testing of islet transplantation. One is the scarcity of islets. Only about 6,000 donor pancreases become available each year, and many are used for whole organ transplantation. Posing another obstacle are the potentially serious side effects — such as anemia, nerve damage, meningitis, and vulnerability to infection — of the medications that stop the immune system from rejecting donor islets. Finally, in some transplanted patients, donor islets function well initially, but in time diabetes recurs. Why the islets die is not well understood.
Recent NIH-funded advances may lead to some answers. “Newly developed immune assays are helping us flesh out a more complete picture of the immune events that trigger rejection,” said Dr. Nancy Bridges, who oversees the consortium for NIAID. “Studies are also laying the groundwork for less toxic immunosuppressive agents, which will be tested in upcoming trials. Our ultimate goal is to develop ways to induce tolerance, a state of immune acceptance of the donor tissue or organ.”
Researchers in the newly funded centers will be designing studies to:
* improve the isolation and viability of islets
* reduce complications of the transplant procedure, e.g., bleeding and clotting
* reduce the side effects of immunosuppression
* trace the fate of islets after transplantation and determine why donor islets sometimes fail
* evaluate new ways to safely prevent immune rejection of donor tissues.
Newly designed studies will be submitted for review by the Food and Drug Administration, the NIDDK/NIAID Islet Transplantation Data and Safety Monitoring Board, and local institutional review boards before being offered to patients. Patient enrollment is scheduled to begin in 2005.
The consortium consists of the following principal investigators and centers:
Dr. William Clarke, University of Iowa (Data Coordinating Center)
Iowa City, Iowa
Dr. Camillo Ricordi, University of Miami
Miami, Florida
Dr. Bernhard Hering, University of Minnesota
Minneapolis, Minnesota
Dr. Ali Naji, University of Pennsylvania
Philadelphia, Pennsylvania
Dr. James Shapiro, University of Alberta
Edmonton, Alberta, Canada
Dr. Olle Korsgren, Uppsala University
Uppsala, Sweden
The consortium is supported by a special funding program for type 1 diabetes research, which provides a total of $1.14 billion from fiscal year 1998 through fiscal year 2008 to supplement other funds for type 1 diabetes research made available through the regular NIH appropriations process.
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