Diabetes
Conditions
Interventions
Subjects in the intervention group will be treated with an ESG with the
endomina ® and TAPES devices (Endo Tools Therapeutics S.A.), both CE-marked for
endoscopic gastroplasty. The endomina is a dev
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age between 18-70 years - Diagnosed with DM2 o since at least 1 year o currently under stable dose of insulin for at least 6 months o with or without use of any other oral glucose lowering medication (e.g., metformin, GLP-1 receptor agonist) - HbA1c level of 6.1-11.0% (43-75 mmol/mol) prior to inclusion - BMI of 30-40 kg/m² - The maximum attainable therapeutic options within standard reimbursed care are obtained (e.g., lifestyle intervention like GLI or dietician and pharmacotherapeutic options like sulfonylureas, metformin, SLGT2 inhibitors, GLP1 agonists and insulin). - Must be eligible for general anesthesia or deep sedation with propofol
Exclusion criteria
Exclusion criteria: • Achalasia and any other esophageal motility disorders • Severe esophagitis (grade C or D) • Gastro-duodenal ulcer • GI stenosis or obstruction • Any history of esophageal or gastric surgery • Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association*s Class III or IV functional capacity • Uncontrolled hypertension (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg under medication) during last 3 months; • Severe renal, hepatic, pulmonary disease or cancer (cancer in the past 5 years, except basal cell carcinoma) • Known with, or history of, eating disorder • Pregnancy, breast feeding or desire to become pregnanct in the coming 12 months • Any previous bariatric surgery, or endoscopic obesity-related intervention (including POSE, OverStitch, etc.). Intragastric balloon removed within the last 6 months • Planned gastric surgery 60 days post intervention • Anticoagulant therapy that cannot be temporarily stopped at the time of the procedure. • Currently participating in another study (involving change of treatment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of subjects with a clinically relevant reduction of insulin dose. A clinically relevant reduction is defined as a 50% dose reduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: Safety: 1. Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure at 12 months 2. (Serious) adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol 3. Cardiovascular events (stroke/TIA, myocardial infarction, admission for heart failure) and all-cause mortality DM2: 4. Proportion of subjects with a clinically relevant decrease of HbA1c after 1 month, 3, 6, and 12 months follow-up. A clinically relevant decrease of HbA1c is defined as 2.6% (5mmol/mol). 5. Reduction in HbA1c after 1 month, 3, 6, and 12 months follow-up. 6. Reduction in fasting plasma glucose levels after 1 month, 3, 6, and 12 months follow-up. 7. Proportion of subjects with reduced number and/or reduced dose(s) of (oral) glucose lowering medication after 1 month, 3, 6, and 12 months follow-up. 8. Proportion of subjects with remission of diabetes after 6, 9 and 12 months. Remission is defined as HbA1c | — |
Countries
Netherlands
Outcome results
None listed