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

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
RECRUITING
Milan
Contact Information
Primary
Luca Vittorio Carlo Valenti
luca.valenti@policlinico.mi.it
02 5503 6595
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2037-12-31
Participants
Target number of participants: 2500
Treatments
Other: PROCEDURES RELATED TO THE STUDY
* Selection of blood donors at risk of NAFLD and metabolic diseases and sample collection blood~* Evaluation of early cardiovascular damage and characterization of liver damage in patients with high probability of severe NAFLD~* Study of genomics and biomarkers~* Generation of an in vitro genetic model of NAFLD
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov