NCT05516576 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
| NCT ID | NCT05516576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-09-29 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
A-L BOREL, MD PHD
PRINCIPAL INVESTIGATOR
University Grenoble Hospital
Frequently Asked Questions
Who can join the NCT05516576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05516576 currently recruiting?
Yes, NCT05516576 is actively recruiting participants. Contact the research team at ESTIME@endotools.be for enrollment information.
Where is the NCT05516576 trial being conducted?
This trial is being conducted at La Tronche, France.
Who is sponsoring the NCT05516576 clinical trial?
NCT05516576 is sponsored by University Hospital, Grenoble. The principal investigator is A-L BOREL, MD PHD at University Grenoble Hospital. The trial plans to enroll 200 participants.
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