Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial

Korábbi kezelés

• Impending gastric surgery 60 days post intervention;
• Patients having alcoholic or drug addiction;

Más betegség

• Type I diabetes characterized by C peptide <0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
• Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
• Patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder;

Életkor

• Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (<5 years)

Egyéb

• Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
• Unstable diabetic retinopathy
• Contra-indication to endoscopic gastroplasty (...)
• Participant involved in another interventional clinical study
• Person deprived of liberty by judicial order
• Person under guardianship or curatorship

• Age between 18-65 years;
• Recently diagnosed Type 2 Diabetes (<= 10 years):
• HbA1c < 9%:
• Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
• Anti-diabetic therapy stable during the last 3 months before inclusion
• BMI between 30-34.9 kg/m² with adaptation for Asian population 27.5-32.5kg/m²
• Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific procedures);
• Must be able to understand and be willing to provide written informed consent.