DIABETES PREVENTION PROGRAM

  • Shamoon, Harry (PI)
  • Shamoon, Harry (PI)

Project: Research project

Project Details

Description

The Diabetes Prevention Program is a randomized clinical trial testing strategies to prevent or delay the development of type 2 diabetes in high-risk persons with elevated fasting plasma glucose concentrations and impaired glucose tolerance. The 27 clinical centers in the U.S.A. are recruiting participants consisting of approximately 50% minorities, 20% F 65 years old, and both sexes, to be assigned at random to one of three intervention groups. Eligible volunteers were randomized to 3 intervention groups: an intensive lifestyle intervention focusing on a healthy diet and exercise, and 2 masked medication treatment groups - metformin, or placebo - combined with standard diet and exercise recommendations. The study design includes 1,000 participants in each of the three treatment groups. Participants are being recruited during a 2.7 year period, and all will be followed for an additional 3.3 to 6 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 6.5% per year in the placebo group. Secondary outcomes include cardiovascular disease and its risk factors; changes in glycemia, beta-cell function, insulin sensitivity, obesity, diet, physical activity, and health-related quality of life; and occurrence of adverse events. A randomized clinical trial will test the possibility of preventing or delaying the onset of type 2 diabetes in persons at high risk.
StatusFinished
Effective start/end date10/1/969/30/01

Funding

  • National Center for Research Resources: $17,678.00

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  • GENERAL CLINICAL RESEARCH CENTER M01 RR12248

    Spiegel, A. M., Purpura, D., Spiegel, A. A. M., Howard, A. A. A., Melman, A. A., Bloom, B. B. R., Diamond, B. B., Segal-isaacson, C. C., Stein, D. D. C., Purpura, D. D., Schoenbaum, E., Kaskel, F. F., Ho, G. G. Y., Shamoon, H., Hetherington, H. H. P., Crystal, H. H., Roy-chowdhury, J. J., Pollard, J. J. W., Rieder, J. J., Crandall, J. J. P., Wylie-Rosett, J., Pan, J. J. W., Rossetti, L. L., Weiss, L. M., Bigal, M. M., Hawkins, M. A., Brownlee, M. M. A., Alderman, M. M. H., Schilsky, M. M. L., Fabry, M. M. E., Roy-chowdhury, N. N., Barzilai, N. N. J., Fleischer, N. N. S., Santoro, N. N. F., Kennan, R. R. P., Bookchin, R. R. M., Klein, R. R. M., Lipton, R. B., Burk, R. R. D., Nagel, R. R. L., Engel, S. S. S., Gupta, S. S., Somlo, S. S., Berk, S. S., Weber, T. T. J., Frishman, W. W. H., Noyer, C. C., Barzilai, N., Burk, R. D., Fabry, M. E., Fleischer, N., Hawkins, M. A., Ho, G. Y., Kaufman, H. L., Nagel, R. L., Roy-Chowdhury, J., Rubenstein, A., Santoro, N. F., Schilsky, M. L., Shamoon, H., Somlo, S., Stein, D. T., Wadler, S. H., Wozniak, R. & Wylie-Rosett, J.

    National Center for Research Resources

    9/30/9711/30/97

    Project: Research project