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 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.
Brief Title
Diabetes Prevention Program
Completion Date
Completion Date Type
Actual
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
Glucose Intolerance
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
* BMI \>= 24 kg/m2
* Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
* BMI \>= 24 kg/m2
Gender
All
Gender Based
false
Keywords
clinical trial
multi-center
NIDDM
NIDDK
Diabetes Prevention Program (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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
25 Years
NCT Id
NCT00004992
Org Class
Nih
Org Full Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Org Study Id
(IND) - DPP (completed)
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Primary Outcomes
Outcome Description
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
Outcome Measure
Development of diabetes
Outcome Time Frame
Up to 5 years
Secondary Ids
Secondary Id
U01DK048489
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
25
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jill Crandall
Investigator Email
jill.crandall@einsteinmed.org
Investigator Phone