Clinical trial
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
Recruiting now · Not applicable · 1 countries · Registry ID NCT05516576
Recruiting nowNot applicableInterventional
What this study is about
The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2, Obesity
Full registry criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU). * Type I diabetes characterized by C peptide \<0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8 * Unstable diabetic retinopathy * Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years); * Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (\<5 years) * Contra-indication to endoscopic gastroplasty (...) * Impending gastric surgery 60 days post intervention; * Participant involved in another interventional clinical study * Patients having alcoholic or drug addiction; * 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; * Person deprived of liberty by judicial order * Person under guardianship or curatorship
Treatments and study arms
endomina®
Device
Endoscopic gastroplasty
Primary outcomes
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity24 months
Remission is defined as HbA1c \< 6.5% without antidiabetic drug for at least 3 months