NCT01501201 Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
| NCT ID | NCT01501201 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Lille |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 490 participants |
| Start Date | 2011-08-08 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 490 participants in total. It began in 2011-08-08 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Francois Pattou, Professor
STUDY DIRECTOR
University Hospital of Lille
Frequently Asked Questions
Who can join the NCT01501201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01501201 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT01501201 currently recruiting?
Yes, NCT01501201 is actively recruiting participants. Contact the research team at fpattou@iv-lille2.fr for enrollment information.
Where is the NCT01501201 trial being conducted?
This trial is being conducted at Lille, France, Angers, France, Bois-Guillaume, France, Boulogne-Billancourt, France and 6 additional locations.
Who is sponsoring the NCT01501201 clinical trial?
NCT01501201 is sponsored by University Hospital, Lille. The principal investigator is Francois Pattou, Professor at University Hospital of Lille. The trial plans to enroll 490 participants.
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