Obesity Clinical Trial
Official title:
Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Verified date | January 2024 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Influence of bariatric endoscopy on change of weight | Influence of bariatric endoscopy on change of weight | 24 months | |
Secondary | Influence of bariatric endoscopy on change of anthropometric parameters | Influence of bariatric endoscopy on change of anthropometric parameters | 24 months | |
Secondary | Anthropometric changes - weight (kg), BMI (kg/m2) | Anthropometric changes - weight (kg), BMI (kg/m2) | 24 months | |
Secondary | Anthropometric changes - waist and hip circumference (cm) | Anthropometric changes - waist and hip circumference (cm) | 24 months | |
Secondary | Nutritional changes (eating habits) - questionnaire survey. | Nutritional changes (eating habits) - questionnaire survey. | 24 months | |
Secondary | Components of the metabolic syndrome - blood pressure (mm/Hg) | Components of the metabolic syndrome - blood pressure (mm/Hg) | 24 months | |
Secondary | Components of the metabolic syndrome - waist circumference (cm) | Components of the metabolic syndrome - waist circumference (cm) | 24 months | |
Secondary | 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 |
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