Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM) (EURDSS)

This is an interventional treatment trial for Atherosclerotic Cardiovascular Disease focused on measuring Type 2 Diabetes Mellitus, BMI 30.0-34.9 kg/m2 Read More

Inclusion Criteria:

• Age 35 to 65 years at eligibility visit.
• Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least he six months prior to enrollment, and HbA 1c > 7.0 %.
• Current treatment for T2DM consisting of multiple doses of insulin with/without hypoglycemic agents or hypoglycemic agents plus basal insulin.
• Optimization of diabetes medical treatment prior to inclusion in the study would have been performed based on best medical practices.
• Body Mass Index (BMI)> 30.0 kg/m2 and <34.9 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.
• 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 (grade II or IV), angina pectoris, symptomatic peripheral vascular disease or advanced cardiovascular disease.
• History of severe hypoglycemic episodes associated with medical treatment of type 2 DM
• Cardiac stress test indicating that surgery 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 or history of coagulopathy.
• Serum creatinine >1.5 mg/dl.
• Serum total bilirubin or alkaline phosphatase greater than the upper limit of normal, or ALT greater than twice the upper limit of normal.
• History of previous surgery contraindicating gastric bypass at the criteria of the surgical team.
• Gastric or duodenal ulcer in the past six months.
• History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
• Currently pregnant or nursing, or planning to become pregnant in the next two years.
• History of alcohol or drug dependency (excluding caffeine and nicotine) in the past five years
• Active psychosocial or psychiatric problem that is likely to interferer with adherence to the protocol.
• Score of 17 or higher on the CES-D (depression scale).
• Current participation in a conflicting research protocol.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• 12-lead EKG indicating that surgery or intensive medical treatment would not be safe.
• Diagnosed with diabetes more than 15 years ago.
• Positive GAD antibodies