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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

557 Scopus citations

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 - 1999

ASJC Scopus subject areas

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

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