Diabetes Prevention Program - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Non-Insulin-Dependent Glucose Intolerance	Behavioral: Intensive lifestyle

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	3819
Study Start Date:	July 1996
Estimated Study Completion Date:	April 2001

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004992

Locations


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

Sponsors and Collaborators

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

National Institute on Aging (NIA)

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


Principal Investigator:	Sarah Fowler, PhD

More Information

The web site of the Diabetes Prevention Program (DPP) This link exits the ClinicalTrials.gov site

Publications of Results:

Florez JC, Jablonski KA, Bayley N, Pollin TI, de Bakker PI, Shuldiner AR, Knowler WC, Nathan DM, Altshuler D; Diabetes Prevention Program Research Group. TCF7L2 polymorphisms and progression to diabetes in the Diabetes Prevention Program. N Engl J Med. 2006 Jul 20;355(3):241-50.

Publications indexed to this study:

Moore AF, Jablonski KA, McAteer JB, Saxena R, Pollin TI, Franks PW, Hanson RL, Shuldiner AR, Knowler WC, Altshuler D, Florez JC; Diabetes Prevention Program Research Group. Extension of type 2 diabetes genome-wide association scan results in the diabetes prevention program. Diabetes. 2008 Sep;57(9):2503-10. Epub 2008 Jun 10.

Franks PW, Jablonski KA, Delahanty L, Hanson RL, Kahn SE, Altshuler D, Knowler WC, Florez JC; Diabetes Prevention Program Research Group. The Pro12Ala variant at the peroxisome proliferator-activated receptor gamma gene and change in obesity-related traits in the Diabetes Prevention Program. Diabetologia. 2007 Dec;50(12):2451-60. Epub 2007 Sep 27.

Study ID Numbers:	DPP, DK48489
First Received:	March 17, 2000
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00004992
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

clinical trial

multi-center

NIDDM

NIDDK

DPP

diabetes risk factors

diabetes

glycemia

cardiovascular risk factors

quality of life

physical activity and nutrition

occurrence of adverse events

insulin secretion and sensitivity

prevention

abnormal glucose metabolism

lifestyle intervention

drug intervention

Study placed in the following topic categories:

Hyperglycemia

Metabolic Diseases

Diabetes Mellitus, Type 2

Glucose Intolerance

Diabetes Mellitus

Quality of Life

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Aging (NIA) 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)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00004992