Bariatric Endoscopy and NAFLD

Study Overview
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Brief Summary
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Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.

Detailed Description
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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 of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.

Official Title
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Influence of Bariatric Endoscopy on Clinical Course of NAFLD

Conditions
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Obesity, NAFLD, Liver Steatosis, Liver Fibrosis

Intervention / Treatment
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* Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
* Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 21-70 years BMI >27 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 Patient living within radio range 300 km from the study center Failure of the cognitive-behavioral approach to weight reduction Exclusion Criteria: Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study: BMI <27 History of gastric surgery. Previous technical difficulties in gastric and duodenal endoscopy or inability to perform endoscopy History of GIT diseases such as achalasia, esophageal motility disorders, severe esophagitis or gastritis, the recent history of ulcers, history of steatosis or obstruction in the GIT Proven celiac disease Previous irreversible endoscopic procedures and surgical treatment of obesity Chronic and acute pancreatitis Active or chronic infectious hepatitis Known liver disease or suspected PBC, PSC, autoimmune hepatitis, alpha1-antitrypsin deficiency, Wilson's disease, hereditary hemochromatosis, known cirrhosis or history of hepatic decompensation, AST or ALT> 5-8x ULN Type 1 or type 2 diabetes with insulin History of malignant disease Specific genetic or hormonal disorders associated with obesity (Prader-Willi syndrome, MC4R mutations, etc.) Serious disorders of blood clotting and hematopoiesis Severe forms of psychiatric illness (endogenous depression, schizophrenia, suicidal tendencies, psychosis) Uncontrolled hypertension (systolic BP> 150 mm Hg or diastolic BP> 100 mm Hg) or severe heart disease (severe cardiac dysfunction, etc.) Serious autoimmune diseases or long-term use treated with glucocorticoids or immunosuppressive therapy Disorders of thyroid function unresponsive to processing. Renal impairment with GFR <60 ml / min / 1.73 m2, or albumin excretion> 1000 mg / day Substance use including excessive alcohol use (> 21 units / week for men and> 14 units / week for women, - 1 unit (250ml 12 ° or 330ml 10 ° beer; 100ml wine; 25ml = small spirits of spirits)) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group with adjustable IGB<br> | Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too<br>* bariatric endoscopy, mainly intragastric balloons, plication of the stomach too<br>|
| Group with non-adjustable IGB<br> | Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too<br>* bariatric endoscopy, mainly intragastric balloons, plication of the stomach too<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis | Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the 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 change of weight | Influence of bariatric endoscopy on change of weight | 24 months | 
| Influence of bariatric endoscopy on change of anthropometric parameters | Influence of bariatric endoscopy on change of anthropometric parameters | 24 months | 
| Anthropometric changes - weight (kg), BMI (kg/m2) | Anthropometric changes - weight (kg), BMI (kg/m2) | 24 months | 
| Anthropometric changes - waist and hip circumference (cm) | Anthropometric changes - waist and hip circumference (cm) | 24 months | 
| Nutritional changes (eating habits) - questionnaire survey. | Nutritional changes (eating habits) - questionnaire survey. | 24 months | 
| Components of the metabolic syndrome - blood pressure (mm/Hg) | Components of the metabolic syndrome - blood pressure (mm/Hg) | 24 months | 
| Components of the metabolic syndrome - waist circumference (cm) | Components of the metabolic syndrome - waist circumference (cm) | 24 months | 
| Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l) | Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l) | 24 months | 

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