Endoscopic sutured gastroplasty with endomina in diabetic, obese patients * prospective interventional study
- Conditions
- Diabetes1001265310017998
- Registration Number
- NL-OMON51445
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
- 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
- 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
- Pregnancy, breast feeding or desire for pregnancy 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a reduction of HbA1C of at least 0.7% one year after<br /><br>ESG.</p><br>
- Secondary Outcome Measures
Name Time Method