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Diabetes Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004992
Recruitment Status : Completed
First Posted : March 20, 2000
Last Update Posted : February 7, 2011
Information provided by:

March 17, 2000
March 20, 2000
February 7, 2011
July 1996
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Complete list of historical versions of study NCT00004992 on ClinicalTrials.gov Archive Site
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Diabetes Prevention Program
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The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited 3819 volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with IGT, impaired glucose tolerance. Each person in the study will be followed for 3 to 6 years.
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Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Glucose Intolerance
Behavioral: Intensive lifestyle
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2001
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Inclusion Criteria:

  • Impaired glucose tolerance (FPG 95-125 mg/dL and 2hr PG 140-199 mg/dL)
  • BMI >= 24 kg/m2

Exclusion Criteria:

  • Underlying disease likely to limit life span and/or increase risk of interventions
  • Conditions or behaviors likely to effect conduct of the DPP
  • Diabetes or disordered glucose metabolism
  • Suboptimally treated Thyroid disease
  • Fasting triglyceride level < 600 mg/dl
  • Exclusions related to medications
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
(IND) - DPP (completed)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute on Aging (NIA)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Office of Research on Women's Health (ORWH)
Principal Investigator: Sarah Fowler, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP