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Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Fatty-Liver-Disease

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Completed
CT.gov ID
NCT05804955
Collaborator
(none)
200
Enrollment
1
Location
65.9
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief 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-Fatty-Liver-Disease has never been explored.

The investigators aimed to assess the alphaGST levels in Metabolic-dysfunction-Associated-Fatty-Liver-Disease patients affected by different stages of liver fibrosis, and, by using a new-designed "Metabolic abnormalities entity- Aspartate aminotransferase/Platelet Ratio-Inflammation-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 200 metabolic dysfunction-associated fatty liver disease patients and a group of 30 healthy controls. All Metabolic-dysfunction-Associated-Fatty-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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Alpha-Glutathione-S-Transferase (AlphaGST) and the MARINA Index as a Novel Predictive Biomarker and Composite Tool for Disease Impairment in the MAFLD Context
    Actual Study Start Date :
    Jan 2, 2017
    Actual Primary Completion Date :
    Jun 30, 2017
    Actual Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis [baseline]

      The diagnostic accuracy of the alpha-Glutathione-S-Transferase (alphaGST) blood levels (pg/ml) in the prediction of hepatic histological-proved advanced fibrosis

    2. MARINA Index prediction of advanced fibrosis [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: (a) Metabolic alterations [plasma triglycerides >150 mg/dl or HDL < 40 mg/dl (men) and < 50 mg/dl (women): 1 point; homeostatic model assessment for insulin resistance (HOMA-IR) > 2.5 or diagnosed diabetes mellitus type 2: 1 point]; (b) Aspartateaminotransferase/Platelet Ratio (< 0.7: 1 point; > 0.7: 2 points); Inflammation (C-reactive protein < 2 mg/L: 1 point; > 2 mg/L: 2 points); Alpha-GST levels (< 3917 pg/ml: 1 point; > 3917 pg/ml: 2 points). MARINA index total scores ranged from 3 to 8 points.

    Secondary Outcome Measures

    1. MARINA index in the prediction of acute cardiovascular events [five years]

      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: (a) Metabolic alterations [plasma triglycerides >150 mg/dl or HDL < 40 mg/dl (men) and < 50 mg/dl (women): 1 point; homeostatic model assessment for insulin resistance (HOMA-IR) > 2.5 or diagnosed diabetes mellitus type 2: 1 point]; (b) Aspartateaminotransferase/Platelet Ratio (< 0.7: 1 point; > 0.7: 2 points); Inflammation (C-reactive protein < 2 mg/L: 1 point; > 2 mg/L: 2 points); Alpha-GST levels (< 3917 pg/ml: 1 point; > 3917 pg/ml: 2 points). MARINA index total scores ranged from 3 to 8 points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • age between 18 and 80 years

    • MAFLD diagnosis

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Campania Luigi Vanvitelli Naples Italy 80138

    Sponsors and Collaborators

    • University of Campania "Luigi Vanvitelli"

    Investigators

    • Principal Investigator: Alessandro Federico, Professor, University of Campania "Luigi Vanvitelli"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alessandro Federico, Professor, University of Campania "Luigi Vanvitelli"
    ClinicalTrials.gov Identifier:
    NCT05804955
    Other Study ID Numbers:
    • 530/2016
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alessandro Federico, Professor, University of Campania "Luigi Vanvitelli"
    Metabolic dysfunction Associated Fatty Liver Disease
    liver fibrosis
    liver cirrhosis
    non-invasive biomarkers
    cardiovascular risk
    Additional relevant MeSH terms:
    Fatty Liver

    Study Results

    No Results Posted as of Apr 7, 2023