The Liver BIoBank Lombardia of Fatty Liver
NCT Number: NCT06566105
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NAFLD|Precision Medicine|Cardiovascular Diseases
Interventions: GENETIC: precision medicine approach
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sex: ALL
Age: ADULT
Enrollment: 2500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-06-01
Completion Date: 2032-12-01
Locations: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milan, Milano, 20122, Italy

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.

Primary Outcome Measures: association of liver fat accumulation, At the time of enrollment, to test the association of liver fat accumulation (HFC) with liver disease and cardiovascular complications the association between HFC-genetic risk score (GRS) data will be collected on the characterization of clinical risk factors through Fibroscan measurement of liver stiffness, liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), in subjects at higher metabolic risk and therefore dysteatosis. This information will be collected in the blood donor subject's management system., up to 48 months|the role of liver fat, The genetic risk score predicts liver fat content (HFC-GRS) can improve risk stratification of liver disease progression in NAFLD and how new common and rare genetic variants contribute to susceptibility to NAFLD. The same data also highlighted a possible new non-invasive circulating biomarker associated with liver fat and lipotoxicity (interleukin-32).

So the evaluation of complete genetic risk scores (GRS) can be used to stratify the risk of liver-related complications and to select the best pharmacological therapy.

Technological advances that enable the interrogation of the entire human genome, combined with the exploitation of bioinformatics systems approaches, are proving promising for providing patients and clinicians with unique health information from the molecular, cellular to multi-organ levels.

By taking advantage of these new technologies, we assessed the role of liver fat (HFC) in coagulation alterations and influence cardiovascular risk., up to 48 months