Actively Recruiting
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Led by Médipôle Lyon-Villeurbanne · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
439 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 to 65 years
- Type 2 diabetes patient with blood sugar goals not met despite medical and nutritional care including physical activity for at least 12 months
- Body mass index (BMI) between 30 and 34.9 kg/m²
- Well informed about metabolic surgery and the study
- Multidisciplinary evaluation including a diabetologist and medical treatment decision before inclusion
- Medical assessment confirming acceptable surgical risk
- Affiliated to or beneficiary of a social security system
- Signed written informed consent freely given
You will not qualify if you...
- Severe cognitive or mental disorders
- Severe and unstable eating behavior disorders
- Dependence on alcohol or psychoactive substances
- Life-threatening illnesses in the short or medium term
- Contraindications to general anesthesia
- No prior medical care identified or inability to participate in lifelong medical monitoring
- History of bariatric surgery
- Pregnant or breastfeeding women, or planning pregnancy within 2 years
- Adult under guardianship or curatorship
- Patient deprived of liberty or under judicial decision
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medipole Lyon Villeurbanne
Villeurbanne, France, 69100
Actively Recruiting
Research Team
L
laetitia paradisi, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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