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

Not Applicable

Recruiting

• Conditions: Obesity; Diabetes Mellitus, Type 2
• Interventions: Device: endomina®

• Registration Number: NCT05516576
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Study Start: 2023-09-29
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2028-11
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic gastroplasty with endomina®	endomina®	-

Primary Outcome Measures

Name	Time	Method
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity	24 months	Remission is defined as HbA1c \< 6.5% without antidiabetic drug for at least 3 months

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 La Tronche, France