Diabetes Mellitus, Non-Insulin-Dependent, Glucose Intolerance
Conditions
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
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.
Interventions
Sponsors
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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of diabetes | 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 |
Countries
United States
Outcome results
None listed