The GATE trial: Endoscopic sutured Gastroplasty in Type 2 diabetic, obese patients using the Endomina device - a randomized controlled trial, and its effect on incretin hormones
- Conditions
- Diabetes1001842410017998
- Registration Number
- NL-OMON53331
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 58
- Age between 18-65 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 7.0-11.0% (53-75 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
• 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method