Omics Techniques in Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Precision Medicine in Fatty Liver Disease: How to Identify the Patient Who Develops Steatohepatitis Using Omics Techniques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05907408
• Other study ID #: NASHOmics1
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Universidade Federal do Rio de Janeiro
• Contact: Guilherme FM Rezende, MD PhD
• Phone: 55+21999976292
• Email: guimottarezende[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease in Western countries and one of the leading causes of liver transplantation in the world. Its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. The reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. The objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Metabolic syndrome

• Liver steatosis detected on transient hepatic elastography performed in the last 12 months

• Steatosis with or without fibrosis confirmed histologically in a liver biopsy performed in the last 12 months

Exclusion Criteria:

• Concurrent liver disease (other than NAFLD)

• Chronic or prolonged use of any potential hepatotoxic drug or substance

• HIV infection

• Cancer (except basal cell carcinoma)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steatosis, without fibrosis or inflammation	Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation	12 months
Primary	Steatohepatitis, with fibrosis	Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis	12 months