Clinical trial NCT01423877: Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: bariatric surgery
diabetes
sleeve gastrectomy
gastric bypass
gastric banding
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bariatric Clinic at Bellevue Hospital

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin Resistance
timeFrame: 6 months
Secondary outcomes:
measure: Vitals status
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
References:
citation: Parikh M, Chung M, Sheth S, McMacken M, Zahra T, Saunders JK, Ude-Welcome A, Dunn V, Ogedegbe G, Schmidt AM, Pachter HL. Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success. Ann Surg. 2014 Oct;260(4):617-22; discussion 622-4. doi: 10.1097/SLA.0000000000000919.