Comparing Gastric By-Pass and Medical Treatment for 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
This study tests whether gastric bypass surgery or medical treatment works better for helping obese patients with type 2 diabetes manage their condition and improve their health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 10 sites (Lille, Nord and 9 other locations) |
| Trial ID | NCT01501201 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Gastric By-Pass surgery against optimized medical therapy in obese patients with poorly controlled type 2 diabetes. It evaluates various outcomes including mortality rates, weight loss, glycemic control, quality of life, and cost-effectiveness of both treatment strategies. The study includes patients with a body mass index between 35 and 50 kg/m2 and an HbA1c level greater than 7.5%. Participants will be monitored for improvements in their diabetes management and overall health following either intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are obese individuals with type 2 diabetes who have an HbA1c level above 7.5% and are eligible for Gastric By-Pass surgery.
Not a fit: Patients who may not benefit from this study include those with contraindications to bariatric surgery, pregnant individuals, and those with psychiatric disorders.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for managing obesity and type 2 diabetes, potentially leading to improved patient outcomes.
How similar studies have performed: Previous studies have shown that bariatric surgery can lead to significant improvements in glycemic control and weight loss, indicating a promising approach for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille, Nord and 9 other locations
- University Hospital of Lille — Lille, Nord, France (Recruiting)
- Centre Hospitalier Regional D' Angers — Angers, France (Recruiting)
- Hopital de Bois-Guillaume Chu Rouen — Bois-Guillaume, France (Recruiting)
- Hu Ouest Site Ambroise Pare Aphp - — Boulogne-Billancourt, France (Recruiting)
- Hopital Jeanne D'Arc Chu Nancy — Dommartin-lès-Toul, France (Recruiting)
- Hopital Lyon Sud - Hcl - Pierre Benite — Lyon, France (Recruiting)
- Hopital Lapeyronie Chu Montpellier — Montpellier, France (Recruiting)
- Hu Pitie Salpetriere Aphp — Paris, France (Recruiting)
- Hopital Larrey Chu Toulouse — Toulouse, France (Recruiting)
- Ch Valenciennes — Valenciennes, France (Recruiting)
Study contacts
- Study coordinator: Francois Pattou, Professor
- Email: fpattou@iv-lille2.fr
- Phone: 00 33 3 20 44 42 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.