The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02036138|
Recruitment Status : Recruiting
First Posted : January 14, 2014
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight Diabetes Type 2||Procedure: Laparoscopic Sleeve Gastrectomy Procedure: Laparoscopic Roux-en-Y Gastric Bypass Drug: Advanced Medical Therapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
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|
- 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 ]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 ]The proportion of patients with a glycated hemoglobin level of less than 6% without diabetes medications.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036138
|Hadassah Medical Organization, Jerusalem, Israel||Recruiting|
|Contact: Hadas Lemberg, PhD 972-6777111|