Diabetes Prevention Program
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Enrollment
- 3234
- Locations
- 1
- Primary Endpoint
- Development of diabetes
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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 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 impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 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
Arms & Interventions
Placebo
Intervention: Placebo
Metformin
Intervention: Metformin
Intensive Lifestyle
Intervention: Intensive lifestyle
Outcomes
Primary Outcomes
Development of diabetes
Time Frame: Up to 5 years
Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association