Status:
RECRUITING
Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
Lead Sponsor:
University Hospital, Lille
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Detailed Description
Optimizing the management of type 2 diabetes (T2D) will remain a major public health concern for decades to come. T2DM has already affected 4% of the French population and generates each year over 12 ...
Eligibility Criteria
Inclusion
- 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
- Contraindication to bariatric surgery
- Pregnancy
- Affiliation of health care assurance
- Psychiatric disorders
Key Trial Info
Start Date :
August 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT01501201
Start Date
August 8 2011
End Date
September 1 2029
Last Update
February 8 2023
Active Locations (10)
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1
University Hospital of Lille
Lille, Nord, France, 59000
2
Centre Hospitalier Regional D' Angers
Angers, France
3
Hopital de Bois-Guillaume Chu Rouen
Bois-Guillaume, France
4
Hu Ouest Site Ambroise Pare Aphp -
Boulogne-Billancourt, France