Diabetes Clinical Trial
Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus
intensive medical weight management on indices of insulin resistance and resolution of type
2 diabetes among patients with BMI 30-35.
Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission
in obese diabetic patients BMI 30-35.
The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin
resistance after either bariatric surgery or initiation of intensive medical weight
management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose
<200mg/dL two hours after a standard 75g oral glucose load without the use of
anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at
6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on
insulin and fasting glucose, as well as oral glucose tolerance tests with
area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will
be derived from electronic health records and patient self-report at 6 months. Secondary
outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and
levels of fasting lipids.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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