Clinical Trial

The Liver BIoBank Lombardia of Fatty Liver

Recruiting
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Summary
NAFLD is most frequently linked to excess adiposity, insulin resistance and cardiometabolic risk factors, it has become the leading cause of liver disease worldwide, and is associated with increased mortality due to multiple causes. HFC has a strong genetic component and the investigators recently showed that it plays a causal role in determining progressive liver disease and insulin resistance. The genetic risk score predicting liver fat content (HFC-GRS) improves the stratification of liver related events, and the investigators have preliminary data on new common and rare variants that contribute to NAFLD susceptibility, and on a new non-invasive circulating biomarker associated with hepatic fat and lipotoxicity (Interleukin-32). However, no data are yet available on the causal role of hepatic fat on the procoagulant state associated with NAFLD, which could participate to liver damage and is a causal factor in atherothrombotic complications. The aim of the study is to examine the potential application of a precision medicine approach to the improvement of stratification of the risk of liver-related and cardiovascular thrombotic complications of hepatic fat accumulation (HFC) and non-alcoholic fatty liver disease (NAFLD), with a special focus on the role of procoagulant imbalance in mediating the at-risk phenotypes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-19.
Trial Details
NCT Number NCT06566105
Lead Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions NAFLD, Precision Medicine, Cardiovascular Diseases
Enrollment 2,500 participants
Start Date 2020-06-01
Primary Completion 2030-06-30 (estimated)
Study Completion 2037-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-18