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Diabetes Prevention Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004992
First Posted: March 20, 2000
Last Update Posted: February 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
Primary Purpose: Prevention

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Investigators
Principal Investigator: Sarah Fowler, PhD
  More Information

Additional Information:
Publications:
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
First Submitted: March 17, 2000
First Posted: March 20, 2000
Last Update Posted: February 7, 2011
Last Verified: February 2011

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes risk factors
diabetes
prevention
clinical trial
multi-center
NIDDM
NIDDK
DPP
glycemia
cardiovascular risk factors
quality of life
physical activity and nutrition
occurrence of adverse events
insulin secretion and sensitivity
abnormal glucose metabolism
lifestyle intervention
drug intervention

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