Comparing endoscopic gastric reduction with standard care for type 2 diabetes and class I obesity

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

This study is testing if a new endoscopic gastric reduction device can help people with type 2 diabetes and class I obesity achieve better diabetes control compared to standard care alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Grenoble (other)
• Locations: 1 site (La Tronche)
• Trial ID: NCT05516576 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the endomina® device for endoscopic gastric reduction in patients with type 2 diabetes and class I obesity. Participants will be randomly assigned to receive either the endoscopic treatment combined with standard care or standard care alone. The primary goal is to determine the impact of this intervention on diabetes remission after 24 months. The study aims to provide insights into a potential new treatment option for managing diabetes in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with recently diagnosed type 2 diabetes and a BMI between 30-34.9 kg/m².

Not a fit: Patients with type I diabetes, severe kidney issues, or contraindications to the endomina® device may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved diabetes management and weight loss for patients with class I obesity.

How similar studies have performed: Other studies have shown promising results with similar endoscopic approaches for obesity and diabetes management, indicating potential for success.

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

Where this trial is running

La Tronche

• Chu Grenoble Alpes — La Tronche, France (RECRUITING)

Study contacts

• Principal investigator: A-L BOREL, MD PHD — University Grenoble Hospital
• Study coordinator: L. LECLERCQ, MSc

Conditions: Diabetes Mellitus, Type 2, Obesity