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"

University Hospital, Lille158 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

158

Conditions

Obesity NASH - Nonalcoholic Steatohepatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Chu Amiens Picardie

Amiens, France

CH ARRAS

Arras, France

CH de Douai

Douai, France

CH LENS

Lens, France

Hop Claude Huriez Chu Lille

Lille, France

GHIRCL saint Philibert

Lomme, France

Ch Valenciennes

Valenciennes, France

Outcomes

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline