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Trial record 1 of 1 for:    NCT00004992
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Diabetes Prevention Program

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ClinicalTrials.gov Identifier: NCT00004992
Recruitment Status : Completed
First Posted : March 20, 2000
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

March 17, 2000
March 20, 2000
March 2, 2018
July 1996
April 2001   (Final data collection date for primary outcome measure)
Development of diabetes [ Time Frame: Up to 5 years ]
Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association
Not Provided
Complete list of historical versions of study NCT00004992 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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 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 impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Glucose Intolerance
  • Behavioral: Intensive lifestyle
  • Drug: Metformin
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Metformin
    Intervention: Drug: Metformin
  • Active Comparator: Intensive Lifestyle
    Intervention: Behavioral: Intensive lifestyle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3234
3819
April 2001
April 2001   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 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
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004992
(IND) - DPP (completed)
U01DK048489 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Institute on Minority Health and Health Disparities (NIMHD)
  • Office of Research on Women's Health (ORWH)
Principal Investigator: Sarah Fowler, PhD George Washington University Biostatistics Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2018

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