RECRUITINGINTERVENTIONAL

The Liver BIoBank Lombardia of Fatty Liver

The Liver BIoBank Lombardia Genomic Cohort Study (LIVER-BIBLE): Personalized Medicine for the Management of Hepatic and Cardiovascular Thrombotic Complications of Fatty Liver

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Blood donors aged between 40 and 65 years presence of clinical diagnosis of overweight or obesity (body mass index-BMI \> 25 kg/m2), - increased fasting blood glucose or T2D (fasting blood glucose ≥100mg/dl) or dyslipidemia (triglycerides≥150mg/dl, HDL\<45/55 in M/F) or arterial hypertension (n = 2,452, 11.8% of the entire cohort). Who Should NOT Join This Trial: - subjects suffering from chronic degenerative diseases, except hypertension in good compensation and diabetes type 2 mellitus which does not require pharmacological therapy (as is already common practice for eligibility for donation of blood) - donors aged \> 65 and \< 40 to avoid the introduction of bias Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Blood donors aged between 40 and 65 years presence of clinical diagnosis of overweight or obesity (body mass index-BMI \> 25 kg/m2), * increased fasting blood glucose or T2D (fasting blood glucose ≥100mg/dl) or dyslipidemia (triglycerides≥150mg/dl, HDL\<45/55 in M/F) or arterial hypertension (n = 2,452, 11.8% of the entire cohort). Exclusion Criteria: * subjects suffering from chronic degenerative diseases, except hypertension in good compensation and diabetes type 2 mellitus which does not require pharmacological therapy (as is already common practice for eligibility for donation of blood) * donors aged \> 65 and \< 40 to avoid the introduction of bias

Treatments Being Tested

GENETIC

precision medicine approach

precision medicine approach to improvement of risk stratification of hepatic and cardiovascular complications in non-alcoholic fatty liver disease in a group of healthy subjects at increased risk of metabolic pathologies

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, Italy