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 (ESTIME)

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Obesity

Diabetes Mellitus, Type 2

Treatments

Device: endomina®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05516576

ST-2019-002

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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