Bariatric Endoscopy and NAFLD

NCT04669470 | Unknown

• 1 other identifier: 08_RVO-FNOs_2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Find out how bariatric endocopy will influence 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 lose

Outcome Measures

Primary Outcomes (1)

• Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis

  Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis

  24 months

Secondary Outcomes (1)

• Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome

  24 months

Study Arms (2)

Group with adjustable IGB

ACTIVE COMPARATOR

Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too

Group with nin-adjustable IGB

ACTIVE COMPARATOR

Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too

Interventions

bariatric endoscopy, mainly intragastric baloons, plication of stomach too PROCEDURE

bariatric endoscopy, mainly intragastric baloons, plication of stomach too

Group with adjustable IGB; Group with nin-adjustable IGB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21-64 years;
• BMI \>30 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.

You may not qualify if:

• Achalasia and any other esophageal motility disorders
• Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
• Hypertension: uncontrolled hypertension during last 3 month
• Severe renal, hepatic, pulmonary disease or cancer;
• GIT stenosis or obstruction
• Pregnancy or breastfeeding
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study
• Celiac disease
• History of bariatric surgery
• Chronic or recent acute pancreatitis
• Type 2 diabetes with insuline medication or type 1 diabetes
• Hematologic disease or disease with impairment of hemocoagulation
• Decompensated psychiatric disease
• Autoimmune disease with chronic glucocorticoid or imunosupressive medications

Sponsors & Collaborators

• University of Ostrava: lead
• University Hospital Olomouc: collaborator
• University Hospital Ostrava: collaborator
• Palacky University: collaborator

Study Sites (1)

Department of gastroenterology, hepatology and pancreatology

Ostrava, 70800, Czechia

RECRUITING

Related Publications (3)

• 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

MeSH Terms

Conditions

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

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

Study Officials

• Adam Vasura, MD

  - Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava

  STUDY CHAIR

• Evzen Machytka

  Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava

  STUDY CHAIR

Central Study Contacts

Adam Vasura

CONTACT

420597374191; obezita@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: December 16, 2020

Record last verified: 2020-11

Locations

CZ (1)