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

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Aug 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with Type 2 diabetes and class I obesity, which is defined as having a body mass index (BMI) between 30 and 34.9. The researchers want to find out if using a special device called the Endomina® to reduce the size of the stomach, along with standard diabetes care, can help improve diabetes control more effectively than just standard care alone. The main goal is to see if this treatment can help participants achieve better blood sugar levels and possibly put their diabetes into remission after two years.

To be eligible for this trial, participants must be between 18 and 65 years old and have been diagnosed with Type 2 diabetes within the last eight years. They should also be taking specific non-insulin medications for their diabetes and have stable health conditions. People with certain health issues, like severe kidney or liver problems, or those involved in other clinical studies, cannot participate. If you join the trial, you can expect regular visits and follow-ups to monitor your health and progress throughout the study. This trial is currently recruiting participants, and your involvement could contribute to important research that helps improve treatment options for diabetes and obesity.

Gender

ALL

Eligibility 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