The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
The growing incidence of obesity and type2 DM globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control. Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized, controlled trials have compared bariatric surgery with intensive medical therapy, particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled, prospective multicenter study was designed to compare intensive medical therapy with surgical treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese patients (BMI 30-34.9) with type- 2 DM.
Diabetes Type 2
Procedure: Laparoscopic Sleeve Gastrectomy
Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Drug: Advanced Medical Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- To assess the efficacy of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in controlling type 2 DM in non-morbid obese patients (BMI 30-34.9) [ Time Frame: 12 MONTHS ] [ Designated as safety issue: No ]The primary end point is the proportion of patients with a glycated hemoglobin level of less than 7% (with or without diabetes medications) 12 months after randomization.
- To assess the safety of intensive medical therapy alone versus medical therapy combines with LRYGB or LSG in diabetic non-morbid obese patients (BMI 30-34.9). [ Time Frame: 12 MONTHS ] [ Designated as safety issue: No ]The proportion of patients with a glycated hemoglobin level of less than 6% without diabetes medications.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Advanced Medical Therapy Patients.
Advanced medical therapy is deﬁned as the use of the latest lifestyle guidelines set forth by the American Diabetes Association to optimize weight loss and glycaemic management, frequent home monitoring/titration strategies, use of latest FDA approved drug therapy (incretin analogues, insulin sensitizers, etc.)
|Drug: Advanced Medical Therapy|
|Experimental: Bariatric Surgery Patients - Roux-en-Y gastric by- pass||Procedure: Laparoscopic Roux-en-Y Gastric Bypass|
|Experimental: Bariatric Surgery Patients -Laparoscopic sleeve gastrectomy||Procedure: Laparoscopic Sleeve Gastrectomy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02036138
|Hadassah Medical Organization, Jerusalem, Israel||Recruiting|
|Contact: Hadas Lemberg, PhD 972-6777111|