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NCT05907408 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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