Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Endo Tools Therapeutics S.A.
First posted: 2022-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Grenoble Hospital
name: A-L BOREL, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: