Bariatric Endoscopy and NAFLD

NCT04895943 | Unknown

• 1 other identifier: 04_RVO-FNOs_2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; NAFLD; Liver Steatosis; Liver Fibrosis

Keywords

Obesity; NAFLD; liver steatosis; liver fibrosis; bariatric endoscopy; weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Influence of bariatric endoscopy on change of weight

  24 months

• Influence of bariatric endoscopy on change of anthropometric parameters

  24 months

• Anthropometric changes - weight (kg), BMI (kg/m2)

  24 months

• Anthropometric changes - waist and hip circumference (cm)

  24 months

• Nutritional changes (eating habits) - questionnaire survey.

  24 months

Study Arms (2)

Group with adjustable IGB

Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

Group with non-adjustable IGB

Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

Interventions

bariatric endoscopy, mainly intragastric balloons, plication of the stomach too PROCEDURE

bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

Group with adjustable IGB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients undergoing bariatric endoscopy procedure.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

• 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.

  PMID: 30683512 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.

  PMID: 21553304 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.

  PMID: 30122876 BACKGROUND

• 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.

  PMID: 39674369 DERIVED

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Body Weight Changes

Study Officials

• Adam Vašura, MD

  University Hospital Ostrava

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 21, 2021
• Study Start: April 29, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)