Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/3/2014 |
| Start Date: | August 2011 |
| End Date: | December 2013 |
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.
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.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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