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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01423877
Study type Observational
Source New York University School of Medicine
Contact
Status Completed
Phase N/A
Start date August 2011
Completion date September 2013

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