Status:
RECRUITING
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Lead Sponsor:
Médipôle Lyon-Villeurbanne
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 possibl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06600555
Start Date
July 3 2024
End Date
December 1 2032
Last Update
September 19 2024
Active Locations (1)
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1
Medipole Lyon Villeurbanne
Villeurbanne, France, 69100