DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

Inclusion criteria

• Age 30 to 67 years at eligibility visit.
• Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %.
• Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
• Willingness to accept random assignment to either treatment group.
• Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
• Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
• Written informed consent.

Exclusion criteria

• Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
• Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
• Cardiac stress test indicating that surgery or IMM would not be safe.
• Pulmonary embolus or thrombophlebitis in the past six months.
• Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
• Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
• Serum creatinine ≥ 1.5 mg/dl.
• HbA1c > 14.0%.