Endoscopic Stomach Stitching Trial for Type 2 Diabetes and Obesity
Tests a stitching device in the stomach with standard care in adults with diabetes.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- La Tronche, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05516576, who can take part
Where in France
- Chu Grenoble AlpesLa Tronche, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT05516576
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Impending gastric surgery 60 days post intervention; Patients having alcoholic or drug addiction; 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; Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (<5 years); 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.