Biomarkers in the Diagnosis and Prognosis of NAFLD

Summary

Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.

Conditions

• NAFLD
• Obesity
• Liver Fibrosis
• Diabetes Mellitus, Type 2

Interventions

DIAGNOSTIC_TEST

Plasma Test

IGF-2 (insulin-like growth factor 2)

DIAGNOSTIC_TEST

Plasma test

SPARC (secreted protein acidic and rich in cysteine)

DIAGNOSTIC_TEST

Plasma test

EPICAN (heparan sulfate proteoglycan)

DIAGNOSTIC_TEST

Plasma test

EGFR (epidermal growth factor receptor)

DIAGNOSTIC_TEST

Liver biopsy

Fibrosis and steatosis grade according to Brunt-Kleiner classification

DIAGNOSTIC_TEST

Visceral adipose tissue biopsy

Presence of inflammation

DIAGNOSTIC_TEST

Liver elastography

Grade of fibrosis according to Hamaguchi score

DIAGNOSTIC_TEST

Blood test

Determination of surrogate based diagnostic tests/scores for liver fibrosis

Sponsors & Collaborators

• University of Trieste

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-22

Primary Completion

2025-09-22

Completion

2026-09-22

Countries

• Italy

Study Locations