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
Recruiting
N/A
Interventional Study
Diabetes Mellitus, Type 2
Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- University Hospital, Grenoble · Other
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About This 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.
Trial Locations
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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 mo…
Contacts