Bariatric Endoscopy and NAFLD

Obesity Clinical Trial

Official title:

Influence of Bariatric Endoscopy on Clinical Course of NAFLD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669470
• Other study ID #: 08_RVO-FNOs_2020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2020
• Source: University of Ostrava
• Contact: Adam Vasura
• Phone: 420597374191
• Email: obezita[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• Liver Steatosis
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

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

Locations

Country	Name	City	State
Czechia	Department of gastroenterology, hepatology and pancreatology	Ostrava

Sponsors (4)

Lead Sponsor	Collaborator
University of Ostrava	Palacky University, University Hospital Olomouc, University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & 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. — 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. Review. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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