Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study
University Hospital, Lille
490 participants
Aug 8, 2011
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- Contraindication to bariatric surgery
- Pregnancy
- Affiliation of health care assurance
- Psychiatric disorders
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Interventions
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
Locations(10)
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NCT01501201