DALLAS, Texas, September 10, 1996 -- UT Southwestern Medical Center at Dallas physicians will soon begin testing a new oral insulin capsule to determine if it can prevent or delay insulin-dependent diabetes mellitus, or type I diabetes, as part of a nationwide clinical study sponsored by the National Institutes of Health (NIH).
The oral insulin intervention study is the second phase of the Diabetes Prevention Trial -- Type I (DPT-1) sponsored by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is designed for people at moderate risk for developing type I diabetes, also known as juvenile-onset diabetes. Phase one, using insulin injections for intervention, was launched in February 1994 and is designed for those at high risk for developing type I diabetes.
For the study UT Southwestern, the only medical center in Texas participating, is recruiting persons between the ages of 3 and 45 who have relatives with type I diabetes. Once enrolled, those at moderate risk -- having a 25 percent to 50 percent chance of developing the disease in five years -- will take one insulin capsule a day. Those at high risk will administer two insulin injections a day.
"Each year, more than 500 new cases of type I diabetes are diagnosed in our community; 120 to 140 of these are at Children's Medical Center, the pediatric teaching hospital for UT Southwestern physicians," said Dr. Philip Raskin, UT Southwestern professor of internal medicine and principal investigator of DPT-1 at UT Southwestern. "Another 17,500 people in the metropolitan area are at risk for developing the disease.
"Through the DPT-1, we hope to find that an insulin capsule or low doses of insulin by injection may prevent or delay diabetes."
Type I diabetics produce very little or no insulin, a hormone that regulates how cells use and store energy from food. It is believed that white blood cells vital to the body's defense against infectious diseases launch a self-directed, or autoimmune, attack on the insulin-producing beta cells in the pancreas. As a result, blood glucose builds to dangerous levels, causing damage to the eyes, kidneys, nerves and heart. Without daily insulin injections, people with type I diabetes will lapse into a coma and die.
Study investigators emphasize that oral insulin cannot be used to treat existing diabetes because it is digested by the body. However, they theorize that giving people insulin capsules or injections before they develop the disease may stop the body's immune system from destroying insulin-producing cells.
UT Southwestern is one of 10 clinics and 350 recruitment sites participating in the DPT-1. The study is sponsored by the NIDDK in cooperation with the National Institute of Child Health and Human Development, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, Juvenile Diabetes Foundation International and American Diabetes Association.
For more information about participating in the study, call (214) 640-5974.