Status:
UNKNOWN
Bariatric Endoscopy and NAFLD
Lead Sponsor:
University of Ostrava
Collaborating Sponsors:
University Hospital Olomouc
University Hospital Ostrava
Conditions:
Obesity
NAFLD
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.
Detailed Description
The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndro...
Eligibility Criteria
Inclusion
- To be eligible for participation in this study, subjects must conform to the following inclusion criteria:
- Age between 21-64 years;
- BMI \>30 Kg/m2
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment , endoscopy, radiography, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
Exclusion
- Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
- Achalasia and any other esophageal motility disorders
- 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.
- Hypertension: uncontrolled hypertension during last 3 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GIT stenosis or obstruction
- Pregnancy or breastfeeding
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
- Celiac disease
- History of bariatric surgery
- Chronic or recent acute pancreatitis
- Type 2 diabetes with insuline medication or type 1 diabetes
- Hematologic disease or disease with impairment of hemocoagulation
- Decompensated psychiatric disease
- Autoimmune disease with chronic glucocorticoid or imunosupressive medications
- Uncontroled disease of thyroid gland
- Excesive abuse of addictive substances such alcohol or other
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04669470
Start Date
October 1 2020
End Date
December 31 2023
Last Update
December 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of gastroenterology, hepatology and pancreatology
Ostrava, Czechia, 70800