Omics Techniques in Fatty Liver Disease

Sponsor

Universidade Federal do Rio de Janeiro (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05907408

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Steatosis Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation
Steatohepatitis Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis

Outcome Measures

Primary Outcome Measures

Steatosis, without fibrosis or inflammation [12 months]
Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation
Steatohepatitis, with fibrosis [12 months]
Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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