Text Size

Diabetes Prevention Program

ClinicalTrials.gov Identifier:
NCT00004992
First received: March 17, 2000
Last updated: February 3, 2011
Last verified: February 2011
History of Changes

March 17, 2000
February 3, 2011
July 1996
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004992 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diabetes Prevention Program
Not Provided

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Glucose Intolerance
Behavioral: Intensive lifestyle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3819
April 2001
Not Provided

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004992
(IND) - DPP (completed), DK48489
Not Provided
Not Provided
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)
Principal Investigator: Sarah Fowler, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2011

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