Diagnostic Accuracy of the LLIFT, a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease. The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.

Official Title
-----------------
Diagnostic Accuracy of the LLIFT, a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome

Conditions
-----------------
Obesity, NASH - Nonalcoholic Steatohepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 1 at least of the following metabolic criteria : BMI > 30 kg/m², Type 2 diabetes (glycemia > 1.26 g/L or under therapy) hypertension (> 140 mmHg / 90 mmHg or under therapy) associated with increased hepatic enzymes Indication of NAFLD evaluation Patients written consent Affiliated to a social insurance Exclusion Criteria: Contraindications for liver biopsy or MRI. Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease. alcohol consumption higher than 140g/week for women and 210g/week for men Previous history of alcohol abuse (addiction). Eluding stent < 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks. Hepatocellular carcinoma Being processed Cancer (chemotherapy, radiotherapy or hormone therapy) Pregnant or breastfeeding women. Drug abuse within the past year. Mentally unbalanced patients, under supervision or guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score | The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score | The variables constituting the algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,..), genetic polymorphism. | Baseline | 
| Assessment of the correlation between the LLIFT score and the NAS score | The NAS score is a stratification based on steatosis, ballooning and lobular inflammation. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFL, NASH screening, metabolic syndrome, Diagnostic Biomarker, non-invasive biomarker