Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
NCT ID: NCT01501201
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
490 participants
INTERVENTIONAL
2011-08-08
2029-09-30
Brief Summary
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Detailed Description
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Bariatric surgery is now a recognized method for the treatment of severe obesity. It allows for the permanent loss of at least 50% of initial excess weight. In obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly T2D. A recent meta-analysis of retrospective studies available suggests that surgery results in remission of T2DM in over 75% of cases. The only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered T2DM. The gastric by-pass (GBP) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. In patients with T2DM, the GBP restores postprandial insulin secretion independently of weight loss. Despite the significant morbidity of the intervention, long-term results seem broadly supportive of the GBP. In a large case-control study, GBP was associated with a decrease of 90% of deaths related to diabetes. In a controlled study conducted in surgical candidates obese diabetics, the GBP decreased the overall world mortality by 75% after 6 years. Despite these very encouraging data, the GBP is now proposed to only a small proportion (\< 1%) of patients likely to benefit from the procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gastric By-Pass
group treated with Gastric By-Pass
Gastric By-Pass
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
optimized medical management
group receiving an optimized medical management
optimized medical management
group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
Interventions
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Gastric By-Pass
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
optimized medical management
group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index \> 35 and \< 50 kg/m2
* Candidate for Gastric By-Pass
* Treatment with GLP1 (glucagon-like peptide) analogue or insulin
Exclusion Criteria
* Pregnancy
* Affiliation of health care assurance
* Psychiatric disorders
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Francois Pattou, Professor
Role: STUDY_DIRECTOR
University Hospital of Lille
Locations
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University Hospital of Lille
Lille, Nord, France
Centre Hospitalier Regional D' Angers
Angers, , France
Hopital de Bois-Guillaume Chu Rouen
Bois-Guillaume, , France
Hu Ouest Site Ambroise Pare Aphp -
Boulogne-Billancourt, , France
Hopital Jeanne D'Arc Chu Nancy
Dommartin-lès-Toul, , France
Hopital Lyon Sud - Hcl - Pierre Benite
Lyon, , France
Hopital Lapeyronie Chu Montpellier
Montpellier, , France
Hu Pitie Salpetriere Aphp
Paris, , France
Hopital Larrey Chu Toulouse
Toulouse, , France
Ch Valenciennes
Valenciennes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010-A01141-38.
Identifier Type: OTHER
Identifier Source: secondary_id
2010_07/1019
Identifier Type: -
Identifier Source: org_study_id
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