Diabetes Prevention Program - Tabular View

Tracking Information

First Received Date ^ICMJE

March 17, 2000

Last Updated Date

November 27, 2006

Start Date ^ICMJE

July 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Diabetes Prevention Program

Official Title ^ICMJE

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 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Diabetes Mellitus, Non-Insulin-Dependent
Glucose Intolerance

Intervention ^ICMJE

Behavioral: Intensive lifestyle

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3819

Completion Date

April 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004992

Responsible Party

Study ID Numbers ^ICMJE

DPP, DK48489

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Sarah Fowler, PhD

Information Provided By

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

Verification Date

July 2003

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