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Diabetes Prevention Program

This study has been completed.
Study NCT00004992.   Last updated on November 27, 2006.   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Diabetes Prevention Program
Official Title 
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  Interventional
Study Design  Prevention, Randomized, Double-Blind, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Diabetes Mellitus, Non-Insulin-Dependent
Glucose Intolerance
Intervention  Behavioral: Intensive lifestyle
MEDLINE PMIDs 16855264
Links The web site of the Diabetes Prevention Program (DPP) This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  3819
Start Date  July 1996
Completion Date April 2001
Eligibility 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
Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00004992
Organization ID DPP
Secondary IDs †† DK48489
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators †† 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        
Information Provided By National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date July 2003
First Received Date  March 17, 2000
Last Updated Date November 27, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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