Omics Techniques in Fatty Liver Disease

June 7, 2023 updated by: Guilherme Rezende, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-630
        • Federal University of Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Quaternary university hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steatosis, without fibrosis or inflammation
Time Frame: 12 months
Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation
12 months
Steatohepatitis, with fibrosis
Time Frame: 12 months
Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Guilherme FM Rezende, MD PhD, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASHOmics1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Alcoholic Fatty Liver Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe