NCT06600555Recruiting
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022. The possible surgical techniques are the same as those for bariatric surgery: * Sleeve, * Bypass, * Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery. The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort. Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data. This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,. If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 3 Jul 2024
- Primary completion date
- 1 Dec 2032
- Lead sponsor
- Médipôle Lyon-Villeurbanne
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06600555
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 3 Jul 2024 to the primary completion date, 1 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
Other illness
- severe cognitive or mental disorders
- severe and unstabilized eating behavior disorders
- illnesses endangering life in the short and medium term
- history of bariatric surgery
Other
- dependence on alcohol and licit and illicit psychoactive substances
- contraindications to general anesthesia
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Médipôle Lyon-Villeurbanne Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.