Diabetes Prevention Program

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hypersensitivity Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd

Rockville, Maryland, 20852, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive lifestyle

Behavioral

metformin

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Aging (NIA)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)

Registry information

Important dates

Study start: 1996
Primary completion: 2001
Study completion: 2001
First posted: Mar 20, 2000
Registry last updated: Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed