NCT06566105Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 1 Jun 2020
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06566105
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 1 Jun 2020 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Age
- donors aged \> 65 and \< 40 to avoid the introduction of bias
Who the study is looking for
- 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).
Age in the registry: 40 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.