Status:
UNKNOWN
Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of actio...
Detailed Description
Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct ...
Eligibility Criteria
Inclusion
- BMI \> 35 kg/m2
- For patients with type 2 diabetes - stable antidiabetic medication \> 1 month
- Age 18-60 years
Exclusion
- Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
- Prior gastrointestinal (GIT) surgery interfering with study procedure
- Severe gastroesophageal reflux, severe GIT motility disorder
- Active malignancy
- Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
- Acute liver or kidney failure
- Transplantation of insulin producing tissue
- Gravidity or lactation
- Mental disorder
- Inability to sign informed consent
- Any other contraindication of bariatric surgery or bariatric endoscopy procedure
- 6\. Acute liver or kidney failure 7. Transplantation of insulin producing tissue 8. Gravidity or lactation 9. Mental disorder 10. Inability to sign informed consent 11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05259644
Start Date
February 1 2022
End Date
December 31 2024
Last Update
February 28 2022
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine
Prague, Czechia, 14021