Status:
COMPLETED
Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35
Lead Sponsor:
NYU Langone Health
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01423877
Start Date
August 1 2011
End Date
September 1 2013
Last Update
April 1 2014
Active Locations (1)
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1
Bellevue Hospital Center
New York, New York, United States, 10016