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

NCT01423877 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2014-04-01

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423877 on ClinicalTrials.gov