Diabetes Prevention Program Pilot Study (DPP)

University of Rochester

Status

Completed

Conditions

Diabetes Prevention

Treatments

Behavioral: DPP

Study type

Interventional

Funder types

Other

Identifiers

NCT00729079

24895

Details and patient eligibility

About

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).

Enrollment

36 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
Currently nursing or within 6 weeks of having completed nursing
Pregnancy anticipated during the course of the trial
Unwilling to undergo pregnancy testing or report possible pregnancy promptly
Unwilling to take adequate contraceptive measures, if potentially fertile
Major psychiatric disorder, including severe active major depression, severe anxiety, schizophrenia, manic depression, bi-polar disorder
Excessive alcohol intake, either acute or chronic
Medications and medical conditions likely to confound the assessment for diabetes including:
- Niacin, in doses indicated for lowering serum triglycerides
- Glucocorticoids, systemic
Other prescription weight-loss medications
Active Thyroid disease, suboptimally treated as indicated by abnormal serum thyroid-stimulating hormone
Other endocrine disorders (e.g., Cushing's syndrome, acromegaly)
Fasting plasma triglyceride >600 mg/dl, despite treatment