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Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with adjustable IGB |
| ||
| Group with non-adjustable IGB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric endoscopy, mainly intragastric balloons, plication of the stomach too | Procedure | bariatric endoscopy, mainly intragastric balloons, plication of the stomach too |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
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Obese patients undergoing bariatric endoscopy procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Vašura, MD | University Hospital Ostrava | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30683512 | Background | Fakhry TK, Mhaskar R, Schwitalla T, Muradova E, Gonzalvo JP, Murr MM. Bariatric surgery improves nonalcoholic fatty liver disease: a contemporary systematic review and meta-analysis. Surg Obes Relat Dis. 2019 Mar;15(3):502-511. doi: 10.1016/j.soard.2018.12.002. Epub 2018 Dec 6. | |
| 21553304 | Background | Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z. |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| bariatric endoscopy, mainly intragastric balloons, plication of the stomach too | Procedure | bariatric endoscopy, mainly intragastric balloons, plication of the stomach too |
|
| 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 |
| 30122876 | Background | Leoni S, Tovoli F, Napoli L, Serio I, Ferri S, Bolondi L. Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis. World J Gastroenterol. 2018 Aug 14;24(30):3361-3373. doi: 10.3748/wjg.v24.i30.3361. |
| 39674369 | Derived | Vasura A, Machytka E, Urban O, Machackova J, Pavliska L, Berka Z, Svagera Z, Buzga M. Effect of bariatric endoscopy on liver fibrosis and steatosis and the course of NAFLD - a prospective interventional study. Ann Hepatol. 2025 Jan-Jun;30(1):101765. doi: 10.1016/j.aohep.2024.101765. Epub 2024 Dec 12. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D001836 | Body Weight Changes |