The Diabetes Prevention Program: Design and methods for a clinical trial in the prevention of type 2 diabetes

G. A. Bray, K. S. Polonsky, P. G. Watson, R. B. Goldberg, S. M. Haffner, R. F. Hamman, E. S. Horton, S. F. Kahn, A. E. Kitabchi, B. E. Metzger, D. M. Nathan, J. M. Olefsky, F. X. Pi-Sunyer, M. J. Prince, R. E. Ratner, M. F. Saad, S. Dagogo Jack, C. D. Saudek, D. S. Schade, H. ShamoonR. R. Wing, R. F. Arakaki, W. C. Krowler, R. Bain, S. M. Marcovina, P. M. Rautaharju, E. J. Mayer-Davis, D. H. O'Leary, E. R. Stamm

Research output: Contribution to journalReview article

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Abstract

The Diabetes Prevention Program is a randomized clinical trial testing strategies to prevent or delay the development of type 2 diabetes in high- risk individuals with elevated fasting plasma glucose concentrations and impaired glucose tolerance. The 27 clinical centers in the U.S. are recruiting at least 3,000 participants of both sexes, ~50% of whom are minority patients and 20% of whom are ≥65 years old, to be assigned at random to one of three intervention groups: an intensive lifestyle intervention focusing on a healthy diet and exercise and two masked medication treatment groups - metformin or placebo - combined with standard diet and exercise recommendations. Participants are being recruited during a 2 2/3-year period, and all will be followed for an additional 3 1/3 to 5 years after the close of recruitment to a common closing date in 2002. The primary outcome is the development of diabetes, diagnosed by fasting or post- challenge plasma glucose concentrations meeting the 1997 American Diabetes Association criteria. The 3,000 participants will provide 90% power to detect a 33% reduction in an expected diabetes incidence rate of at least 6.5% per year in the placebo group. Secondary outcomes include cardiovascular disease and its risk factors; changes in glycemia, β-cell function, insulin sensitivity, obesity, diet, physical activity, and health-related quality of life; and occurrence of adverse events. A fourth treatment group - troglitazone combined with standard diet and exercise recommendations - was included initially but discontinued because of the liver toxicity of the drug. This randomized clinical trial will test the possibility of preventing or delaying the onset of type 2 diabetes in individuals at high risk.

Original languageEnglish (US)
Pages (from-to)623-634
Number of pages12
JournalDiabetes care
Volume22
Issue number4
DOIs
StatePublished - Jan 1 1999
Externally publishedYes

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ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Bray, G. A., Polonsky, K. S., Watson, P. G., Goldberg, R. B., Haffner, S. M., Hamman, R. F., Horton, E. S., Kahn, S. F., Kitabchi, A. E., Metzger, B. E., Nathan, D. M., Olefsky, J. M., Pi-Sunyer, F. X., Prince, M. J., Ratner, R. E., Saad, M. F., Dagogo Jack, S., Saudek, C. D., Schade, D. S., ... Stamm, E. R. (1999). The Diabetes Prevention Program: Design and methods for a clinical trial in the prevention of type 2 diabetes. Diabetes care, 22(4), 623-634. https://doi.org/10.2337/diacare.22.4.623