Diabetes Prevention Program Pilot Study

Completed · Not applicable

Conditions studied: Diabetes Prevention

In brief

This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).

Key facts

Study ID

NCT00729079

Run by

University of Rochester

People needed

36

Starts

2008-12-01

Expected to finish

2009-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age >18 years
• BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
• IGT (2-h plasma glucose 140\~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
• Elevated FPG (95\~125 mg/dl*).
• HDL-triglyceride ration > 3.5.

You may not qualify if…

• Diabetes at baseline
• FPG >126 mg/dl*
• 2-h plasma glucose >200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
• Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
• Ever used antidiabetic medication, other than during pregnancy
• Medical conditions likely to limit life span and/or increase risk of intervention
• Cardiovascular disease
• Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class> 2
• Left bundle branch block or third degree AV block Aortic stenosis
• Systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg
• Cancer requiring treatment in the past 5 years, unless the prognosis is considered good
• Renal disease (creatinine GFR < or = 30 ml/hr or > 2.0 mg/dl if GFR not available).
• Anemia (hematocrit <36% in men or <33% in women)
• Hepatitis (based on history or serum transaminase elevation)
• Other gastrointestinal disease (pancreatitis, acute inflammatory bowel disease)
• Recent or significant abdominal surgery
• Pulmonary disease with dependence on oxygen or daily use of bronchodilators
• Chronic infection (e.g., HIV, active tuberculosis)
• Conditions or behaviors likely to affect conduct of the trial
• Unable to communicate with clinic staff (e.g., read and speak English).
• Unwilling to accept treatment assignment by randomization
• Participation in another intervention research project that might interfere with DPP
• Weight loss of > 10% in past 6 months for any reason except postpartum weight loss
• Unable to walk 0.25 miles in 10 min
• Currently pregnant or within 3 months postpartum

Where it is running

• Clinton Medical Associated — Rochester, New York, United States
• Therapeutic Lifestyle Changes — Rochester, New York, United States

Full record on ClinicalTrials.gov

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