Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566105
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-07
Brief Title:
The Liver BIoBank Lombardia of Fatty Liver
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The aims of the project will be
To examine whether a comprehensive HFC-GRS coupled with evaluation of environmental triggers imaging techniques and novel circulating biomarkers help in stratifying of the risk of NAFLD and associated complications in a cohort of asymptomatic individuals at high risk from the general population the Liver-Bible cohort The Liver-Bible cohort is made up of 2500 individuals with multiple metabolic risk factors who are undergoing a comprehensive evaluation of environmental exposure HFC and liver stiffness measurement liver histology in those at risk of advanced fibrosis circulating biomarkers of hepatic damage coagulation status and early cardiovascular damage
To validate the causal role of HFC in the alterations of metabolism coagulation and early cardiovascular damage associated with NAFLD
To identify new inherited risk variants and microbiota profiles associated with NAFLD to investigate the mechanism linking genetic susceptibility with liver disease and coagulation balance in in vitro models of NAFLD in hepatocytes sinusoidal endothelial cells and hepatic stellate cells The investigators expect to demonstrate that the combined evaluation of genetic and novel circulating biomarkers with imaging improves the non-invasive prediction of both liver-related leading to personalised and cost-effective surveillance of liver-related complications and unrelated complications of NAFLD in at risk individuals with a special focus on the role of the coagulation balance and to pinpoint new genetic modifiers of disease progression that may be prioritized for future therapeutic approaches
To examine whether a comprehensive HFC-GRS coupled with evaluation of environmental triggers imaging techniques and novel circulating biomarkers help in stratifying of the risk of NAFLD and associated complications in a cohort of asymptomatic individuals at high risk from the general population the Liver-Bible cohort The Liver-Bible cohort is made up of 2500 individuals with multiple metabolic risk factors who are undergoing a comprehensive evaluation of environmental exposure HFC and liver stiffness measurement liver histology in those at risk of advanced fibrosis circulating biomarkers of hepatic damage coagulation status and early cardiovascular damage
To validate the causal role of HFC in the alterations of metabolism coagulation and early cardiovascular damage associated with NAFLD
To identify new inherited risk variants and microbiota profiles associated with NAFLD to investigate the mechanism linking genetic susceptibility with liver disease and coagulation balance in in vitro models of NAFLD in hepatocytes sinusoidal endothelial cells and hepatic stellate cells The investigators expect to demonstrate that the combined evaluation of genetic and novel circulating biomarkers with imaging improves the non-invasive prediction of both liver-related leading to personalised and cost-effective surveillance of liver-related complications and unrelated complications of NAFLD in at risk individuals with a special focus on the role of the coagulation balance and to pinpoint new genetic modifiers of disease progression that may be prioritized for future therapeutic approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None