Diabetes Prevention Program - Full Text View

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

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

Drug Information available for: 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)

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

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 January 06, 2009