Diabetes Prevention Program Pilot Study

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