Bariatric Endoscopy and NAFLD

Study Overview
=================
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 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.

Official Title
-----------------
Influence of Bariatric Endoscopy on Clinical Course of NAFLD

Conditions
-----------------
Obesity, NAFLD, Liver Steatosis, Liver Fibrosis

Intervention / Treatment
-----------------
* Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group with adjustable IGB<br> | Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too<br>* bariatric endoscopy, mainly intragastric baloons, plication of stomach too<br>|
| Active Comparator: Group with nin-adjustable IGB<br> | Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too<br>* bariatric endoscopy, mainly intragastric baloons, plication of stomach too<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome | Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight lose