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" (LLIFT)

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 Overview

• Status: Completed
• Conditions: Obesity; NASH - Nonalcoholic Steatohepatitis

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie
  • Arras, France
    • CH Arras
  • Douai, France
    • CH de DOUAI
  • Lens, France
    • CH LENS
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille
  • Lomme, France
    • GHIRCL saint Philibert
  • Valenciennes, France
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients are followed in the cardiology, endocrinology, hepatology, hepatologic surgery and bariatric surgery units of the CHU de Lille and regional centers and presente type 2 diabetes or blood pressure hypertension associated with increased hepatic enzyme.

Patients will be referred to the hepatology units and included in the study

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Région Nord-Pas de Calais, France; RHU PreciNASH Task 1.4
• Investigators: Principal Investigator: Guillaume Lassailly, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: metabolic syndrome; NAFL; Diagnostic Biomarker; non-invasive biomarker; NASH screening
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Fatty Liver; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2019_45; 2020-A01991-38 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No