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Recruiting Phase 4 NCT01501201
Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
Trial Parameters
Condition Obesity
Sponsor University Hospital, Lille
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 490
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2011-08-08
Completion 2029-09
Interventions
Gastric By-Passoptimized medical management
Brief Summary
The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.
Eligibility Criteria
Inclusion Criteria: * Type 2 diabetes mellitus with HbA1c \> 7.5 % * Body mass index \> 35 and \< 50 kg/m2 * Candidate for Gastric By-Pass * Treatment with GLP1 (glucagon-like peptide) analogue or insulin Exclusion Criteria: * Contraindication to bariatric surgery * Pregnancy * Affiliation of health care assurance * Psychiatric disorders
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