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Not yet recruitingNCT05907408Updated Jun 18, 2023

Omics Techniques in Fatty Liver Disease

An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by Universidade Federal do Rio de Janeiro. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Universidade Federal do Rio de Janeiro · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease

Keywords

  • nonalcoholic fat liver disease
  • NASH
  • metabolic fat liver disease
  • risk factors
  • noninvasive markers
  • transcriptomics
  • metabolomics
  • proteomics
  • liver fibrosis
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 10 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Universidade Federal do Rio de Janeiro is the lead sponsor of 120 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Quaternary university hospital

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

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)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
10 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Steatosis, without fibrosis or inflammation

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

    Time frame: 12 months

  2. Steatohepatitis, with fibrosis

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

    Time frame: 12 months

07

Study locations

1 site
  • Federal University of Rio de Janeiro
    Rio de Janeiro, RJ 21941-630, Brazil
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make individual participant data available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05907408
Lead sponsor
Universidade Federal do Rio de Janeiro
Responsible party
Guilherme Rezende (Associate Professor, Universidade Federal do Rio de Janeiro) — Principal investigator
First posted
Jun 18, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jun 18, 2023

Study contacts

Guilherme FM Rezende, MD PhD
Contact
guimottarezende@gmail.com
55+21999976292
Regina CS Goldenberg, BSND PhD
Contact
rcoeli@biof.ufrj.br
55+21999913066
Guilherme FM Rezende, MD PhD
principal investigator · Universidade Federal do Rio de Janeiro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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