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)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: endomina®

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: L. LECLERCQ, MSc; Phone Number: +3271919409; Email: ESTIME@endotools.be

Study Locations

• France
  • La Tronche, France, 38043
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Anne-Laure BOREL, MDD; Email: ALBorel@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: endoscopic gastroplasty with endomina®	Device: endomina®; Endoscopic gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Endo Tools Therapeutics S.A.
• Investigators: Principal Investigator: A-L BOREL, MD PHD, university grenoble hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: ST-2019-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No