September 10, 1996 Bethesda, MD--The National Institutes of Health (NIH) announces the launch of a nationwide clinical study to determine if taking a capsule of insulin crystals can prevent or delay type 1 diabetes, also called insulin-dependent or juvenile diabetes.
The oral insulin intervention is the second phase of the Diabetes Prevention Trial--Type 1 (DPT-1) and is designed for people at moderate risk for developing diabetes. Phase one, the insulin injection intervention, was launched in February 1994 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the NIH. The injection phase enrolls volunteers at high risk for developing diabetes.
"Preliminary studies conducted on animals have shown that it may be possible to prevent type 1 diabetes with insulin," says Phillip Gorden, M.D., NIDDK director. "The DPT-1 seeks to answer the question of whether insulin capsules or insulin by injection can prevent diabetes in people at moderate and high risk for the disease."
Researchers at 10 NIH-sponsored centers and more than 350 recruiting centers across the country are screening individuals for the study. Volunteers must have a relative with type 1 diabetes and be age 3 to 45 years. People interested in finding out if they are eligible can call 1-800-HALTDM-1 (1-800-425-8361).
Study investigators emphasize that insulin crystals cannot be used to treat diabetes because they are digested by the body. However, giving people insulin capsules may stop the body's immune system from destroying insulin-producing cells. This process is called "oral tolerization."
Dr. Jay Skyler, Study Chair and Professor of Medicine and Pediatrics explains, "In type 1 diabetes the body's immune system destroys the insulin producing cells in the pancreas. Our studies test whether we can alter the balance between protective and destructive immune system cells and halt the destructive process."
Each year, 13,000 new cases of type 1 diabetes are diagnosed in children and teen-agers, making it one of the most common chronic diseases in U.S. children. People with type 1 diabetes do not produce insulin, a hormone that regulates how cells obtain energy from food. T-cells produced by the body's immune system mistakenly destroy insulin-producing cells. As a result, sugar levels build 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 eventually die.
The DPT-1 is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases 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.
DPT-1's Web page: http://www.niddk.nih.gov/patient/dpt_1/dpt_1.htm
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CONTACT: Lorraine Marchand
National Institute of
Diabetes and Digestive
and Kidney Diseases
(301) 496-3583 | | Lisa Rafkin
Diabetes Prevention Trial -Type 1
Coordinating Center
(305) 243-6146 |
