The Liver BIoBank Lombardia of Fatty Liver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- precision medicine approach
Treatment groups
2,500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov