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Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients

RECRUITINGPhase 4Sponsored by University Hospital, Lille
Actively Recruiting
PhasePhase 4
SponsorUniversity Hospital, Lille
Started2011-08-08
Est. completion2029-09
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT01501201

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions2

DiabetesObesity

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