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Design of Clinical Trial
Underway
The clinical trial known as SHOW (Study of Health Outcomes of Weight Loss) is now in the design stage. The trialone of the largest clinical trials ever to be conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)will examine the impact of weight-loss interventions on health in obese individuals with type 2 diabetes. In September 1999, NIDDK, along with 5 other Federal cosponsors, selected 16 clinical centers throughout the United States and named Wake Forest University, Winston-Salem, NC, as the data coordinating center. The principal investigators of each center are collaborating with NIDDK on the trial design. "All of the investigators are very excited about this opportunity to determine the long-term health impacts of intensive lifestyle interventions designed to produce sustained weight loss in a large number of individuals," said Barbara Harrison, special project officer in NIDDK's Division of Digestive Diseases and Nutrition and coordinator of the SHOW trial. "The complexity of a trial this size will require intensive planning and design over the next year before recruitment can begin."
A chair and co-chair were named after the first SHOW trial steering committee meeting held in October 1999. Rena R. Wing, Ph.D., is steering committee chair and principal investigator for the clinical center at the Miriam Hospital, Brown University, in Providence, RI. Dr. Wing is professor of psychiatry and human behavior at Brown, and professor of psychiatry, psychology, and epidemiology at the University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic. She has also been director of the NIDDK University of Pittsburgh Obesity/Nutrition Research Center. The steering committee co-chair, F. Xavier Pi-Sunyer, M.D., is principal investigator for the clinical center at St. Luke's-Roosevelt Institute for Health Sciences in New York City. Dr. Pi-Sunyer is also director of the institute's Obesity/Nutrition Research Center, supported by NIDDK. Approximately 6,000 patients are expected to be recruited over a 3-year period, with at least 4 additional years of treatment and followup. Study organizers hope to include a large number of African American and Hispanic American adults in SHOW. Native Americans will be recruited through NIDDK's Epidemiology and Clinical Research Branch in Phoenix, AR, which has been studying obesity and diabetes in Pima Indians, a population with an extraordinarily high incidence of both of these diseases.
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