Diabetes Prevention Program

February 28, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Metformin
Drug: Metformin
Active Comparator: Intensive Lifestyle
Behavioral: Intensive lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

Investigators

  • Principal Investigator: Sarah Fowler, PhD, George Washington University Biostatistics Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

March 17, 2000

First Submitted That Met QC Criteria

March 17, 2000

First Posted (Estimate)

March 20, 2000

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (IND) - DPP (completed)
  • U01DK048489 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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