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

Obesity Clinical Trial

— ESTIME  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516576
• Other study ID #: ST-2019-002
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: University Hospital, Grenoble
• Contact: Loulia LECLERCQ, PhD
• Phone: +32499532030
• Email: loulia.leclercq[@]endotools.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 18-65 years;

• Recently diagnosed Type 2 Diabetes (< 8 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Device:
• endomina®
Endoscopic gastroplasty

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	La Tronche

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Endo Tools Therapeutics S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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