IU School of Medicine Receives Funding To Study Means To Delay Diabetes' Onset

INDIANAPOLIS - The Indiana University School of Medicine has received a $2 million National Institutes of Health grant to seek ways to delay or reverse the onset of type 1 diabetes, also known as juvenile diabetes.

The study, known as Type 1 Diabetes TrialNet, is a 7-year clinical trial and Indiana University is the only site in the Midwest and only one of 14 in the nation involved. The research trial at IU School of Medicine is a collaborative effort between Henry Rodriguez, M.D., assistant professor of pediatric endocrinology, and Mark Pescovitz, M.D., professor of surgery.

The trial is designed to identify therapeutic agents to delay the onset of type 1 diabetes in those at risk for developing the disease or reverse the course of the disease in newly diagnosed patients. Type 1 diabetes most frequently occurs in children, but also can develop in adults under the age of 40.

The incidence of type 1 diabetes is on the rise, said Dr. Rodriguez, the principal investigator for the IU trial. Juvenile diabetes affects as many as three people in 1,000 in the general population, he said. However, the risk of developing the disease is greater than tenfold higher for first-degree relatives of individuals with type 1 diabetes.

Through an earlier clinical trial at Riley Hospital for Children, Dr. Rodriguez and his colleagues identified relatives at risk. That trial, known as the Diabetes

Prevention Trial - Type 1, screened first-degree relatives of children with diabetes to identify those at risk for developing the disease.

Children determined to be at medium risk were given minimal daily doses of oral insulin to see if it would prevent or delay onset of diabetes. That portion of the clinical trial is ongoing. Those at high risk, determined to have a greater than 50 percent chance of developing diabetes within 5 years, were given small doses of injectable insulin twice a day and intravenous insulin for 4 days each year.

The National Institute of Diabetes and Digestive Disorders, a division of the NIH which funded the Diabetes Prevention Trial and TrialNet, concluded at the end of the high-risk trial that injectable insulin, in the manner given, does not delay the onset of diabetes in individuals at high risk.

"It is unknown what causes type 1 diabetes, but through TrialNet we are hopeful we can determine ways to reduce the number of children who are forced to live with this devastating disease," said Dr. Rodriguez.

Researchers now are seeking an effective means to prevent the development of diabetes in young people. Physicians at the various TrialNet centers will establish protocols and the actual clinical trials are expected to begin in early 2002.

One protocol physicians at IU School of Medicine are reviewing is the use of immunosuppressant drugs to delay or reverse the damage caused by the body to cells in the pancreas. That damage is what causes type 1 diabetes, an autoimmune disease that results from the body attacking its own insulin-producing beta cells in the pancreas. The diabetic can no longer produce insulin.

Dr. Pescovitz is a transplant surgeon and an expert in immunosuppressant therapies. Since type 1 diabetes is an autoimmune disorder, Dr. Pescovitz's role in the clinical trial will be to evaluate the effect of pharmaceutical agents used to prevent the body from attacking itself, which is a major hurdle for patients who have had organ transplants.

Dr. Pescovitz and his immunology team and Dr. Rodriguez and the Riley diabetes team currently are evaluating the use of the immunosuppressive drug daclizumab in people with newly diagnosed type 1 diabetes.

"The body has a built-in mechanism for protecting itself against viruses and other unnatural agents," said Dr. Pescovitz. "When the body identifies organs, or in this case beta cells, and thinks they are foreign objects and tries to reject them, then immunosuppressants are effective tools. We are hoping that these drugs are as effective with type 1 diabetes as they are with organ transplant patients."

For additional information on the clinical trial, contact Linda Amstutz, R.N., the pediatric diabetes research nurse coordinator, at 317-274-2574.

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Media Contact: Mary Hardin
317-274-7722
mhardin@iupui.edu

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