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Trial record 1 of 1 for:    NCT00004992
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Diabetes Prevention Program

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00004992     History of Changes
Other Study ID Numbers: (IND) - DPP (completed), DK48489
Study First Received: March 17, 2000
Last Updated: February 3, 2011
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on June 18, 2013