NL-OMON53331
Not yet recruiting
Not Applicable
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 - GATE trial
niversitair Medisch Centrum0 sites58 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- niversitair Medisch Centrum
- Enrollment
- 58
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
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;
Outcomes
Primary Outcomes
Not specified
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