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

NCT05804955 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2024-05-16

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Alessandro Federico, Professor · University of Campania Luigi Vanvitelli

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2017-06-30
Completion
2022-07-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804955 on ClinicalTrials.gov