Bariatric Endoscopy and NAFLD

Influence of Bariatric Endoscopy on Clinical Course of NAFLD

Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.

Study Overview

• Status: Recruiting
• Conditions: Obesity; NAFLD; Liver Steatosis; Liver Fibrosis
• Intervention / Treatment: Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too

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 in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake.

Current state of knowledge:

Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Vasura; Phone Number: 420597374191; Email: obezita@fno.cz

Study Locations

• Czechia
  • Ostrava, Czechia, 70800
    • Recruiting
    • Department of gastroenterology, hepatology and pancreatology
    • Contact: Adam Vasura; Phone Number: +420597374191

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be eligible for participation in this study, subjects must conform to the following inclusion criteria:

1. Age between 21-64 years;
2. BMI >30 Kg/m2
3. 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.
4. Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria:

• Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:

  1. Achalasia and any other esophageal motility disorders
  2. 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.
  3. Hypertension: uncontrolled hypertension during last 3 month
  4. Severe renal, hepatic, pulmonary disease or cancer;
  5. GIT stenosis or obstruction
  6. Pregnancy or breastfeeding
  7. Impending gastric surgery 60 days post intervention;
  8. Currently participating in other study
  9. Celiac disease
  10. History of bariatric surgery
  11. Chronic or recent acute pancreatitis
  12. Type 2 diabetes with insuline medication or type 1 diabetes
  13. Hematologic disease or disease with impairment of hemocoagulation
  14. Decompensated psychiatric disease
  15. Autoimmune disease with chronic glucocorticoid or imunosupressive medications
  16. Uncontroled disease of thyroid gland
  17. Excesive abuse of addictive substances such alcohol or other

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group with adjustable IGB	Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too; bariatric endoscopy, mainly intragastric baloons, plication of stomach too
Active Comparator: Group with nin-adjustable IGB	Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too; bariatric endoscopy, mainly intragastric baloons, plication of stomach too

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome	Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome	24 months

Collaborators and Investigators

• Sponsor: University of Ostrava
• Collaborators: University Hospital Ostrava; University Hospital Olomouc; Palacky University
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; NAFLD; liver fibrosis; liver steatosis; bariatric endoscopy; weight lose
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 08_RVO-FNOs_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No