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

NCT05516576 | Recruiting DMC

• 1 other identifier: ST-2019-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (1)

• Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity

  Remission is defined as HbA1c \< 6.5% without antidiabetic drug for at least 3 months

  24 months

Study Arms (2)

endoscopic gastroplasty with endomina®

EXPERIMENTAL

Device: endomina®

control

NO INTERVENTION

Interventions

endomina® DEVICE

Endoscopic gastroplasty

endoscopic gastroplasty with endomina®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Endo Tools Therapeutics S.A.: collaborator

Study Sites (1)

Chu Grenoble Alpes

La Tronche, 38043, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• A-L BOREL, MD PHD

  University Grenoble Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L. LECLERCQ, MSc

CONTACT

+3271919409; ESTIME@endotools.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 25, 2022
• Study Start: September 29, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 14, 2025

Record last verified: 2024-12

Locations

FR (1)