Comparing endoscopic gastric reduction with standard care for type 2 diabetes and class I obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the endomina® device for endoscopic gastric reduction in patients with type 2 diabetes and class I obesity. Participants will be randomly assigned to receive either the endoscopic treatment combined with standard care or standard care alone. The primary goal is to determine the impact of this intervention on diabetes remission after 24 months. The study aims to provide insights into a potential new treatment option for managing diabetes in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Grenoble Alpes
  La Tronche, France Recruiting

Study contacts

• Principal investigator: A-L Borel, Md Phd — University Grenoble Hospital
• Study coordinator: L. LECLERCQ, MSc
• Email: ESTIME@endotools.be
• Phone: +3271919409

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Clazakizumab for adults with high hsCRP at risk for a heart event

  This study tests whether clazakizumab can lower inflammation and reduce cardiovascular risk in adults with high hsCRP and existing risk factors.

  Recruiting at 32 sites Phase 2 Eli Lilly and Company · Huntsville, Alabama and 45 other locations · NCT07783802

• AI-assisted lifestyle plan vs. tirzepatide for obesity with newly diagnosed type 2 diabetes

  This study tests whether an AI-guided lifestyle program can help overweight adults with newly diagnosed type 2 diabetes lose more weight and improve blood sugar control compared with tirzepatide or standard lifestyle care.

  Recruiting at 5 sites Phase 4 The First Affiliated Hospital of Anhui Medical University · Hefei, Anhui and 4 other locations · NCT07697391

• Long-term test of maridebart cafraglutide for obesity and type 2 diabetes

  This extension study tests whether maridebart cafraglutide remains effective and safe for people with obesity and type 2 diabetes who previously completed a parent trial.

  Recruiting at 45 sites Phase 3 Amgen · Gilbert, Arizona and 44 other locations · NCT07684144

• Tirzepatide in real-world Paraguay for obesity and type 2 diabetes

  This study tests tirzepatide in adults in Paraguay to see how it works for weight loss and blood sugar control in everyday clinical practice.

  Recruiting Phase 4 Las Rías Medical Center · Asunción · NCT07588438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.