The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|