NL-OMON51445
Withdrawn
Phase 2
Endoscopic sutured gastroplasty with endomina in diabetic, obese patients * prospective interventional study - GATE-study
niversitair Medisch Centrum0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- niversitair Medisch Centrum
- Enrollment
- 40
- Status
- Withdrawn
- 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 but diagnosed no longer than 10 years ago
- •o currently under stable dose of insulin for at least 6 months
- •\- HbA1c level of 7\.0\-11\.0% (53\-75 mmol/mol)
- •\- BMI of 30\-40 kg/m² with or without hypertension
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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