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Date: Monday, June 10, 1996 FOR IMMEDIATE RELEASE Contact: NIDDK Lorraine Marchand,(301) 496-3583, San Francisco,(415) 905-1053 or (415) 905-1055 (fax)
SAN FRANCISCO -- The National Institutes of Health (NIH) announced today the first nationwide research study to determine whether Type 2 diabetes can be prevented or delayed in people likely to develop the disease.
Called the Diabetes Prevention Program, the study will examine whether lowering blood sugar levels in people with a condition called "impaired glucose tolerance" (IGT) can help prevent or delay development of Type 2 diabetes. IGT is a precursor to diabetes. People with IGT have high blood sugar, but not high enough to be diagnosed as diabetes.
The study is seeking 4,000 participants who have IGT-- including people with a family history of diabetes, overweight individuals, and women who had diabetes during pregnancy, (gestational diabetes).
"Approximately 21 million Americans have higher than normal blood sugar levels or IGT. Most of these people don't know they have IGT and that they may be at risk for developing Type 2 diabetes sometime during their lives," said Phillip Gorden, M.D., director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). "The Diabetes Prevention Program will study two new classes of diabetes drugs and lifestyle changes, all of which have been proven in smaller studies to lower blood sugar and help prevent progression of IGT to Type 2 diabetes."
The study seeks 2,000 minority volunteers, including African Americans, Hispanic Americans, American Indians, and Asian and Pacific Island Americans, all of whom have disproportionately high rates of Type 2 diabetes. Twenty percent of volunteers will be age 65 or older and 20 percent will be women who have had gestational diabetes.
"This country has seen a tripling of diabetes over the past 30 years, and as baby boomers continue to age, gain weight and remain inactive, Type 2 diabetes will only become more common, more costly and more destructive," said Frank Vinicor, M.D., M.P.H., president of the American Diabetes Association. "We are proud to support the Diabetes Prevention Program and are confident it will yield results that will benefit millions of Americans at risk for this serious disease.
Volunteers will be randomly assigned to one of four groups: intensive lifestyle changes to reduce weight by seven percent; intervention with the drug metformin, currently used to treat Type 2 diabetes; intervention with the drug troglitazone, currently being tested for treatment of Type 2 diabetes; and the control group, who will take placebo pills in place of the two drugs and will receive information on diet and exercise.
"The Diabetes Prevention Program investigators are confident that one or more of the interventions will be effective in decreasing the development of Type 2 diabetes," said David M. Nathan, M.D., the study chairman.
Approximately 15 million Americans have Type 2 diabetes, and half don't know it yet. Another 21 million Americans have IGT and half of them go on to develop Type 2 diabetes. Diabetes costs the U.S. $92.6 billion a year. With Type 2 diabetes, the body cannot effectively use insulin, the hormone that regulates how cells use sugar from food. As a result, blood sugar levels can build to dangerously high levels, causing damage to the eyes, kidneys, nerves and heart. Diabetes is a leading cause of blindness, amputation, kidney failure, heart attacks and strokes in adults in the United States.
Twenty-five medical centers nationwide are participating in the Diabetes Prevention Program. Volunteers can call 1-888-377-5646 (1-888-DPP JOIN) for a list of participating centers.The announcement was made by the National Institute of Diabetes and Digestive and Kidney Diseases of NIH at the American Diabetes Association annual meeting.
The Diabetes Prevention Program is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH. It also is supported by the National Institute of Child Health and Human Development, National Institute on Aging, Office of Research on Minority Health, Indian Health Service, Centers for Disease Control and Prevention, and the American Diabetes Association. Corporate support is being provided by: Bristol-Myers Squibb Company, Health o meter, Inc., Lifescan, Inc., Lipha Pharmaceuticals, Inc., Parke- Davis, and Sankyo Pharmaceutical Co.