Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
DIABSURG
2 other identifiers
interventional
66
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 obesity
Started Aug 2011
Longer than P75 for phase_4 obesity
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedMay 22, 2026
May 1, 2026
8.1 years
December 20, 2011
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall mortality
to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality
5 years
Secondary Outcomes (6)
overall mortality
7 years
overall mortality
10 years
weight loss
2 years
glycemic control
2 years
quality of life
2 years
- +1 more secondary outcomes
Study Arms (2)
Gastric By-Pass
EXPERIMENTALgroup treated with Gastric By-Pass
optimized medical management
ACTIVE COMPARATORgroup receiving an optimized medical management
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication to bariatric surgery
- Pregnancy
- Affiliation of health care assurance
- Psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University Hospital of Lille
Lille, Nord, 59000, 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, 69008, France
Hopital Lapeyronie Chu Montpellier
Montpellier, France
Hu Pitie Salpetriere Aphp
Paris, France
Hopital Larrey Chu Toulouse
Toulouse, France
Ch Valenciennes
Valenciennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francois Pattou, Professor
University Hospital of Lille
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 29, 2011
Study Start
August 8, 2011
Primary Completion
September 27, 2019
Study Completion
September 27, 2019
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share