Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35

Completed

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01423877

Run by

NYU Langone Health

People needed

55

Starts

2011-08-01

Expected to finish

2013-09-01

Last updated by the study team

2014-04-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients eligible for study are adults (age ≥ 18) with type 2 diabetes who have a BMI 30-35, and are insured by Metroplus insurance, but otherwise meet NIH Consensus Criteria specifically (1) overweight for at least 5 years, (2) failure to lose weight with non-surgical means, (3) absence of medical or psychological contraindications, and (4) patient understanding of the procedure and its risks, and strong motivation to comply with the post-surgical regimen. Patients must have permission from their physician to participate in the study.

You may not qualify if…

• Exclusions include being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks), participation in other obesity- or diabetes-related clinical trials, or diagnosis of cognitive dysfunction or significant psychiatric comorbidity.

Where it is running

• Bellevue Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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