Omics Techniques in Fatty Liver Disease

NCT05907408 | Unknown

• 1 other identifier: NASHOmics1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

nonalcoholic fat liver disease; NASH; metabolic fat liver disease; risk factors; noninvasive markers; transcriptomics; metabolomics; proteomics; liver fibrosis

Outcome Measures

Primary Outcomes (2)

• Steatosis, without fibrosis or inflammation

  Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation

  12 months

• Steatohepatitis, with fibrosis

  Patients with non-alcoholic fatty liver disease presenting with steatosis and degree \>1 of liver fibrosis

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Quaternary university hospital

You may qualify if:

• 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

You may not qualify if:

• Concurrent liver disease (other than NAFLD)
• Chronic or prolonged use of any potential hepatotoxic drug or substance
• HIV infection
• Cancer (except basal cell carcinoma)

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-630, Brazil

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guilherme FM Rezende, MD PhD

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme FM Rezende, MD PhD

CONTACT

55+21999976292; guimottarezende@gmail.com

Regina CS Goldenberg, BSND PhD

CONTACT

55+21999913066; rcoeli@biof.ufrj.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)