NCT06098417

Biomarkers in the Diagnosis and Prognosis of NAFLD

Recruiting now Last updated 24 October 2023

What this trial tests

trial testing Plasma Test in NAFLD in 500 participants. Currently enrolling.

Timeline

22 September 2015

Primary endpoint
22 September 2025

22 September 2026

Quick facts

Lead sponsor	University of Trieste
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	22 September 2015
Primary completion	22 September 2025
Estimated completion	22 September 2026
Sites	1 location across Italy

Drugs / interventions tested

• Plasma Test
• Plasma test
• Plasma test
• Plasma test
• Liver biopsy — full drug profile →
• Visceral adipose tissue biopsy
• Liver elastography
• Blood test — full drug profile →

Conditions studied

• NAFLD — all drugs for NAFLD →
• Obesity — all drugs for Obesity →
• Liver Fibrosis — all drugs for Liver Fibrosis →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

University of Trieste

Who can join

Adults 18 to 65, any sex, with NAFLD or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammatory Proteomic Heterogeneity Beyond Glycemia Status in Severe Obesity.
   Milito MM, Chiesa M, Mallia A, Papaianni GG, et al · · 2026 · PMID 42123728 · DOI 10.3390/ijms27094152
2. Low-Abundance Proteomics Reveal Pleiotrophin and Fibroblast Growth Factor-21 as Biomarkers of Metabolic Dysfunction-Associated Steatohepatitis.
   Milito MM, Mihajlovic M, Mallia A, Ghilardi S, et al · · 2025 · PMID 41303424 · DOI 10.3390/ijms262210943