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Bariatric Endoscopy and NAFLD

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ClinicalTrials.gov Identifier: NCT04669470
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborators:
University Hospital Olomouc
University Hospital Ostrava
Palacky University
Information provided by (Responsible Party):
University of Ostrava

Study Description
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Brief Summary:
Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.

Condition or disease Intervention/treatment Phase
Obesity NAFLD Liver Steatosis Liver Fibrosis Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too Not Applicable

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 syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake.

Current state of knowledge:

Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group with adjustable IGB Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
Active Comparator: Group with nin-adjustable IGB Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too
bariatric endoscopy, mainly intragastric baloons, plication of stomach too


Outcome Measures
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Primary Outcome Measures :
  1. Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis [ Time Frame: 24 months ]
    Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis


Secondary Outcome Measures :
  1. Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome [ Time Frame: 24 months ]
    Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for participation in this study, subjects must conform to the following inclusion criteria:

  1. Age between 21-64 years;
  2. BMI >30 Kg/m2
  3. 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.
  4. Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria:

  • Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:

    1. Achalasia and any other esophageal motility disorders
    2. 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.
    3. Hypertension: uncontrolled hypertension during last 3 month
    4. Severe renal, hepatic, pulmonary disease or cancer;
    5. GIT stenosis or obstruction
    6. Pregnancy or breastfeeding
    7. Impending gastric surgery 60 days post intervention;
    8. Currently participating in other study
    9. Celiac disease
    10. History of bariatric surgery
    11. Chronic or recent acute pancreatitis
    12. Type 2 diabetes with insuline medication or type 1 diabetes
    13. Hematologic disease or disease with impairment of hemocoagulation
    14. Decompensated psychiatric disease
    15. Autoimmune disease with chronic glucocorticoid or imunosupressive medications
    16. Uncontroled disease of thyroid gland
    17. Excesive abuse of addictive substances such alcohol or other
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669470


Contacts
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Contact: Adam Vasura 420597374191 obezita@fno.cz

Locations
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Czechia
Department of gastroenterology, hepatology and pancreatology Recruiting
Ostrava, Czechia, 70800
Contact: Adam Vasura    +420597374191      
Sponsors and Collaborators
University of Ostrava
University Hospital Olomouc
University Hospital Ostrava
Palacky University
Investigators
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Study Chair: Adam Vasura, MD - Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
Study Chair: Evzen Machytka Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
More Information
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Publications:

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Responsible Party: University of Ostrava
ClinicalTrials.gov Identifier: NCT04669470    
Other Study ID Numbers: 08_RVO-FNOs_2020
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Ostrava:
Obesity
NAFLD
liver steatosis
 liver fibrosis
bariatric endoscopy
weight lose
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Fatty Liver
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases