Liver Fibrosis, Liver Steatosis, NAFLD, Obesity
Conditions
Keywords
Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight loss
Brief summary
Find out how bariatric endoscopy will influence the 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 of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.
Interventions
PROCEDUREbariatric endoscopy, mainly intragastric balloons, plication of the stomach too
bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
Sponsors
University Hospital Ostrava
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of bariatric endoscopy on change of anthropometric parameters | 24 months | Influence of bariatric endoscopy on change of anthropometric parameters |
| Anthropometric changes - weight (kg), BMI (kg/m2) | 24 months | Anthropometric changes - weight (kg), BMI (kg/m2) |
| Anthropometric changes - waist and hip circumference (cm) | 24 months | Anthropometric changes - waist and hip circumference (cm) |
| Influence of bariatric endoscopy on change of weight | 24 months | Influence of bariatric endoscopy on change of weight |
| Components of the metabolic syndrome - blood pressure (mm/Hg) | 24 months | Components of the metabolic syndrome - blood pressure (mm/Hg) |
| Components of the metabolic syndrome - waist circumference (cm) | 24 months | Components of the metabolic syndrome - waist circumference (cm) |
| Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l) | 24 months | Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l) |
| Nutritional changes (eating habits) - questionnaire survey. | 24 months | Nutritional changes (eating habits) - questionnaire survey. |
Countries
Czechia
Outcome results
None listed