Non-Alcoholic Fatty Liver DiseaseNCT05907408
Omics Techniques in Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 31 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Quaternary university hospital
Who may be able to join
- 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
Who cannot join
- Concurrent liver disease (other than NAFLD)
- Chronic or prolonged use of any potential hepatotoxic drug or substance
- HIV infection
- Cancer (except basal cell carcinoma)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-630
About this study
Official title: 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.
- 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
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Steatosis, without fibrosis or inflammation
Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation
Measured: 12 months
Steatohepatitis, with fibrosis
Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Rezende, Universidade Federal do Rio de Janeiro
- Investigators
- Guilherme FM Rezende, MD PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907408
- Sponsor's protocol ID
- NASHOmics1
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Fatty Liver Disease: How to Identify the Patient Who Develops Steatohepatitis Using Omics Techniques
- ClinicalTrials.gov ID
- NCT05907408
- Acronym / sponsor ID
- NASHOmics1
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- nonalcoholic fat liver disease, NASH, metabolic fat liver disease, risk factors, noninvasive markers, transcriptomics, metabolomics, proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Quaternary university hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Concurrent liver disease (other than NAFLD)
- Chronic or prolonged use of any potential hepatotoxic drug or substance
- HIV infection
- Cancer (except basal cell carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Steatosis, without fibrosis or inflammation
Time frame: 12 months
Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation
Steatohepatitis, with fibrosis
Time frame: 12 months
Patients with non-alcoholic fatty liver disease presenting with steatosis and degree >1 of liver fibrosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
Related trials for Non-Alcoholic Fatty Liver Disease
Active, not recruitingPhase 2
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
NASH
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Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme FM Rezende, MD PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme FM Rezende, MD PhD (55+21999976292, guimottarezende@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steatosis, without fibrosis or inflammation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.