Fatty LiverNCT05804955
Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Steatotic-Liver-Disease (MASLD)
An observational study of Fatty Liver, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
AlphaGST represents a liver enzyme whose serologic levels progressively increase in alcoholic and viral chronic hepatitis according to the worsening of liver fibrosis. However, its diagnostic and prognostic usefulness in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease has never been explored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatty Liver
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2017to 1 Jul 2022
- How long will I take part?
- 5 Years
- 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 80 years
- All sexes
- Adult, Older adult
Study population: After signing the informed consent, the investigators consecutively enrolled patients affected by ultrasonographic detectable bright-liver presenting the MAFLD diagnostic features:1) overweight or obesity, defined as Body Mass Index >25 kg/m2; 2) type 2 diabetes mellitus; 3) presence of ≥ two metabolic risk abnormalities identified by (a) waist circumference ≥102 cm in men (≥ 88 cm in women), (b) blood pressure ≥ 130/85 mmHg (or specific drug treatment), (c) plasma triglycerides ≥150 mg/dL (or specific drug treatment), (d) plasma high-density-lipoprotein cholesterol < 40 mg/dL for men (<50 mg/dL for women) (or specific drug treatment), (e) prediabetes (fasting plasma glucose levels 100-125 mg/dL) or 2-hour post-load glucose levels 140-199 mg/dL or glycated hemoglobin 5.7%-6.4%, (f) homeostasis-model-assessment-for-insulin-resistance score ≥2.5, (g) plasma high-sensitivity C-reactive protein level > 2 mg/L.
Who may be able to join
- age between 18 and 80 years
- MASLD diagnosis
Who cannot join
- presence of chronic inflammatory diseases
- acute or chronic kidney diseases
- rheumatoid arthritis, systemic lupus erythematosus, or other major systemic inflammatory diseases or tumors
- ongoing infections
- alcohol or drug abuse history
- other etiologies of chronic liver damage
Show all 10Show fewer
- previous hepatocellular carcinoma diagnosis
- use of hepatoprotective drugs
- decompensated liver cirrhosis (Child-Pugh B and Child-Pugh C) at the moment of the enrollment or in the previous 12 months
- psychological/psychiatric problems that could have invalidated the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alpha-Glutathione-S-Transferase (AlphaGST) and the MARINA Index as a Novel Predictive Biomarker and Composite Tool for Disease Impairment in the MASLD Context
AlphaGST represents a liver enzyme whose serologic levels progressively increase in alcoholic and viral chronic hepatitis according to the worsening of liver fibrosis. However, its diagnostic and prognostic usefulness in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease has never been explored.
The investigators aimed to assess the alphaGST levels in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease patients affected by different stages of liver fibrosis, and, by using a new-designed "Metabolic Abnormalities Related to lipids- Insulin resistance-AlphaGST levels" (MARINA) index, to evaluate its role as a novel non-invasive tool in the disease staging stratification, identification of the advanced fibrosis and prediction of 5-years acute cardiovascular events occurrence.
The investigators enrolled 30 ehalthy controls and 200 metabolic dysfunction-associated steatotic liver disease patients (Training cohort) (TrC). As a validation cohort (VlC), between January 2018 and May 2019, 60 MASLD patients were consecutively enrolled (Validation Cohort - VlC) All Metabolic-dysfunction-Associated- Steatotic-Liver-Disease patients received an ultrasound-guided percutaneous liver biopsy for the disease staging. Liver stiffness measurement, NAFLD fibrosis score, Fibrosis-4, and body mass index-aspartate aminotransferase/Platelet Ratio-Diabetes scores as well as the MARINA index were determined. Naïve-acute cardiovascular events patients were subsequently followed up over 5 years to record acute cardiovascular events occurrence.
- Conditions
- Fatty Liver
- Keywords
- Metabolic dysfunction Associated Steatotic Liver Disease, liver fibrosis, liver cirrhosis, non-invasive biomarkers, cardiovascular risk
- Medical subject headings
- Fatty Liver, 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 |
|---|---|---|
| Training Cohort | 200 MASLD patients | |
| Validation Cohort | 60 MASLD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis
The diagnostic accuracy of the alpha-Glutathione-S-Transferase (alphaGST) blood levels (pg/ml) in the prediction of hepatic histological-proved advanced fibrosis
Measured: baseline
MARINA Index prediction of advanced fibrosis
The diagnostic accuracy of the MARINA index in the prediction of hepatic histological-proved advanced fibrosis. The MARINA index was calculated by combining the following variables: HLD > 43.5 mg/dl (no: 1 point; yes: 2 points); HbA1c > 5.5% (no: 1 point; yes: 2 points); AlphaGST > 3917 pg/ml (no: 2 point; yes: 4 point). MARINA index total scores ranged from 3 to 8 points.
Measured: baseline
Secondary outcomes (1)
MARINA index in the prediction of acute cardiovascular events
The accuracy of the MARINA index in the prediction of Acute Cardiovascular Events 5 years occurrence. The MARINA index was calculated by combining the following variables: HLD > 43.5 mg/dl (no: 1 point; yes: 2 points); HbA1c > 5.5% (no: 1 point; yes: 2 points); AlphaGST > 3917 pg/ml (no: 2 point; yes: 4 point). MARINA index total scores ranged from 3 to 8 points.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start2 Jan 2017
- Primary completion30 Jun 2017
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Federico, University of Campania Luigi Vanvitelli
- Investigators
- Alessandro Federico, Professor, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804955
- Sponsor's protocol ID
- 530/2016
- Status last verified
- May 2024
- First submitted
- 3 Mar 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-Glutathione-S-Transferase (AlphaGST) and the MARINA Index as a Novel Predictive Biomarker and Composite Tool for Disease Impairment in the MASLD Context
- ClinicalTrials.gov ID
- NCT05804955
- Acronym / sponsor ID
- 530/2016
- Conditions
- Fatty Liver
- Keywords
- Metabolic dysfunction Associated Steatotic Liver Disease, liver fibrosis, liver cirrhosis, non-invasive biomarkers, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 7 Apr 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.
AlphaGST represents a liver enzyme whose serologic levels progressively increase in alcoholic and viral chronic hepatitis according to the worsening of liver fibrosis. However, its diagnostic and prognostic usefulness in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease has never been explored.
The investigators aimed to assess the alphaGST levels in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease patients affected by different stages of liver fibrosis, and, by using a new-designed "Metabolic Abnormalities Related to lipids- Insulin resistance-AlphaGST levels" (MARINA) index, to evaluate its role as a novel non-invasive tool in the disease staging stratification, identification of the advanced fibrosis and prediction of 5-years acute cardiovascular events occurrence.
The investigators enrolled 30 ehalthy controls and 200 metabolic dysfunction-associated steatotic liver disease patients (Training cohort) (TrC). As a validation cohort (VlC), between January 2018 and May 2019, 60 MASLD patients were consecutively enrolled (Validation Cohort - VlC) All Metabolic-dysfunction-Associated- Steatotic-Liver-Disease patients received an ultrasound-guided percutaneous liver biopsy for the disease staging. Liver stiffness measurement, NAFLD fibrosis score, Fibrosis-4, and body mass index-aspartate aminotransferase/Platelet Ratio-Diabetes scores as well as the MARINA index were determined. Naïve-acute cardiovascular events patients were subsequently followed up over 5 years to record acute cardiovascular events occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | –200 MASLD patients |
| Validation Cohort | – | –60 MASLD patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- After signing the informed consent, the investigators consecutively enrolled patients affected by ultrasonographic detectable bright-liver presenting the MAFLD diagnostic features:1) overweight or obesity, defined as Body Mass Index >25 kg/m2; 2) type 2 diabetes mellitus; 3) presence of ≥ two metabolic risk abnormalities identified by (a) waist circumference ≥102 cm in men (≥ 88 cm in women), (b) blood pressure ≥ 130/85 mmHg (or specific drug treatment), (c) plasma triglycerides ≥150 mg/dL (or specific drug treatment), (d) plasma high-density-lipoprotein cholesterol < 40 mg/dL for men (<50 mg/dL for women) (or specific drug treatment), (e) prediabetes (fasting plasma glucose levels 100-125 mg/dL) or 2-hour post-load glucose levels 140-199 mg/dL or glycated hemoglobin 5.7%-6.4%, (f) homeostasis-model-assessment-for-insulin-resistance score ≥2.5, (g) plasma high-sensitivity C-reactive protein level > 2 mg/L.
Key inclusion criteria (2 listed)
- age between 18 and 80 years
- MASLD diagnosis
Key exclusion criteria (10 listed)
- presence of chronic inflammatory diseases
- acute or chronic kidney diseases
- rheumatoid arthritis, systemic lupus erythematosus, or other major systemic inflammatory diseases or tumors
- ongoing infections
- alcohol or drug abuse history
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
Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis
Time frame: baseline
The diagnostic accuracy of the alpha-Glutathione-S-Transferase (alphaGST) blood levels (pg/ml) in the prediction of hepatic histological-proved advanced fibrosis
MARINA Index prediction of advanced fibrosis
Time frame: baseline
The diagnostic accuracy of the MARINA index in the prediction of hepatic histological-proved advanced fibrosis. The MARINA index was calculated by combining the following variables: HLD > 43.5 mg/dl (no: 1 point; yes: 2 points); HbA1c > 5.5% (no: 1 point; yes: 2 points); AlphaGST > 3917 pg/ml (no: 2 point; yes: 4 point). MARINA index total scores ranged from 3 to 8 points.
1 secondary outcome
MARINA index in the prediction of acute cardiovascular events
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
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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.
Alessandro Federico, Professor principal investigator
University of Campania Luigi Vanvitelli
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 Fatty Liver, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 16 May 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis (time frame: baseline). 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 16 May 2024.