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University of Rochester Medical Center to Test Investigational Drug to Prevent or Delay Diabetes

Will Conduct Free Screening for Children and Adults at Risk for Diabetes

Tuesday, September 10, 1996

The Pediatric Endocrinology Unit at the University of Rochester Medical Center is joining a national effort to offer free blood tests to people who have relatives with Type 1 diabetes and to determine if taking insulin capsules can indeed prevent or delay the disease in those who are at moderate risk for the disease.To be eligible for the free screening and for consideration in a clinical trial of insulin capsules, individuals between the ages of 3 and 45 must have a relative -- brother, sister, parent, aunt, uncle, cousin, grandparent -- who has Type 1 diabetes.Participation in the screening and the clinical trial is free. For more information and to arrange for a screening, individuals/parents can call the Pediatric Endocrinology Unit at (716) 275-2932."The value of the free screening is to help individuals determine if they are at risk for this type of diabetes. We think this screening is particularly valuable for children and we encourage parents to consider it if Type 1 diabetes runs in the family," says the study's Rochester-area leader, Nicholas Jospe, M.D., associate professor of pediatrics at the Medical Center. "Participation in this trial will help us determine if this intervention can prevent or delay a serious and lifelong disease."If screening results show that a person is at risk for developing diabetes, he or she will take additional tests to determine eligibility for the clinical trial. If enrolled, those at moderate risk for Type 1 diabetes may take one insulin capsule a day. Those at high risk may take two insulin injections daily.What is Type 1 Diabetes?People with Type 1 diabetes (known as insulin-dependent or juvenile diabetes) do not produce insulin, a hormone that regulates how cells get energy from food. The reason for this non-production is that T-cells produced by the body's immune system may mistakenly destroy insulin-producing cells, with the result that sugar levels build up to dangerous levels in the blood, causing damage to the eyes, kidneys, nerves, and heart. Without daily insulin injections, people with Type 1 diabetes will lapse into a coma and die.(Type II diabetes is noninsulin-dependent diabetes; it afflicts mostly overweight adults over 40. In Type II, the body does produce insulin, but it can not use it effectively. The dangers are similar to Type 1.)How Prevention May WorkFor those who are at moderate risk for Type 1 diabetes, an oral dose of insulin crystals -- in the form of a capsule -- may influence the T-cells not to destroy the body's insulin-producing cells, hence, preventing or at least delaying the onset of the disease.Interestingly, oral doses of insulin crystal are not effective for controlling the disease after onset, but the crystals are thought to be effective against the unchecked behavior of the T-cells. This process is known as "oral tolerization."Individuals deemed to be at high risk will likely be enrolled in the arm of the clinical trial that utilizes low dose injections of insulin to try to delay or prevent the onset of diabetes.Sponsorship

The study of insulin capsules and injections as a way of preventing or delaying Type 1 diabetes is known as DPT-1 -- Diabetes Prevention Trial - Type 1 -- and is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. More than 350 recruiting centers across the nation are participating.

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