Fatty Liver Clinical Trial
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
NCT number | NCT05804955 |
Other study ID # | 530/2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2, 2017 |
Est. completion date | July 1, 2022 |
Verified date | May 2024 |
Source | University of Campania "Luigi Vanvitelli" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | July 1, 2022 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - age between 18 and 80 years - MASLD 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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of Campania Luigi Vanvitelli | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | baseline | |
Primary | 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. | baseline | |
Secondary | 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. | five years |
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