A project to understand fatty liver disease and its complications
Official title: The Liver BIoBank Lombardia Genomic Cohort Study (LIVER-BIBLE): Personalized Medicine for the Management of Hepatic and Cardiovascular Thrombotic Complications of Fatty Liver
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06566105 · Data updated 2026-11-12
This study is trying to understand how genetics and lifestyle affect fatty liver disease in people at high risk, by looking at their liver health and heart risks through various tests.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 60 Years |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | June 1, 2020 |
| Main results expected | June 30, 2030 |
| Study ends | December 31, 2037 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06566105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are blood donors aged 40 to 65 with overweight or obesity and metabolic risk factors such as increased blood glucose or dyslipidemia.
✕Probably not a fit
Patients with chronic degenerative diseases other than well-managed hypertension or type 2 diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to investigate the role of genetic factors and environmental triggers in non-alcoholic fatty liver disease (NAFLD) among individuals at high risk. It will utilize a comprehensive genetic risk score, imaging techniques, and novel biomarkers to assess liver health and associated cardiovascular risks. The study will involve over 2,500 participants who will undergo extensive evaluations, including liver stiffness measurements and histology, to better understand the progression of NAFLD and its complications. The goal is to enhance non-invasive prediction methods for liver-related issues and improve personalized care.
Why it matters
Potential benefit: If successful, this project could lead to improved risk stratification and personalized management of NAFLD, potentially reducing liver-related complications.
How similar studies have gone: Other studies have shown promise in using genetic and biomarker approaches to understand NAFLD, but this specific combination of methods is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Milano, Italy Recruiting
Study contacts
- Study coordinator: Luca Vittorio Carlo Valenti
- Email: luca.valenti@policlinico.mi.it
- Phone: 02 5503 6595
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.