Evaluating surgical options for improving diabetes management
CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
This study tests whether different types of weight-loss surgery can help people with type 2 diabetes and moderate obesity better manage their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Médipôle Lyon-Villeurbanne Academic / other |
| Locations | 1 site (Villeurbanne) |
| Trial ID | NCT06600555 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different metabolic surgery techniques, specifically sleeve and bypass surgeries, in achieving glycemic improvement for patients with type 2 diabetes and moderate obesity. The research aims to provide comparative data on these surgical approaches, which have recently been recommended for diabetes management. Patients will be followed up after undergoing the chosen surgical intervention to assess outcomes related to their diabetes control. The study addresses a gap in existing literature regarding the objective selection of surgical techniques based on effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with type 2 diabetes who have not achieved glycemic control despite comprehensive medical management and have a BMI between 30 and 34.9 kg/m².
Not a fit: Patients with severe cognitive or mental disorders, unstable eating behavior disorders, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management and remission for patients with type 2 diabetes through tailored surgical interventions.
How similar studies have performed: While metabolic surgery is a recent recommendation for diabetes management, this study aims to fill a gap in comparative effectiveness data, indicating that similar approaches have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patient and ≤ 65 years old * T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months * BMI between 30 and 34.9 kg/m² * patient well informed beforehand about metabolic surgery and the study * multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion) * medical assessment of an acceptable surgical risk * patient affiliated to or beneficiary of a social security system * patient having freely signed the written informed consent Exclusion Criteria: * severe cognitive or mental disorders * severe and unstabilized eating behavior disorders * dependence on alcohol and licit and illicit psychoactive substances * illnesses endangering life in the short and medium term * contraindications to general anesthesia * absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring * history of bariatric surgery * pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (\< 2 years) * adult patient under guardianship or curatorship * patient deprived of liberty or under judicial decision
Where this trial is running
Villeurbanne
- Medipole Lyon Villeurbanne — Villeurbanne, France (Recruiting)
Study contacts
- Study coordinator: laetitia paradisi, Dr
- Email: l.paradisi-prieur@resamut.fr
- Phone: 0033481655296
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.