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"

NCT04616664 | Completed

• 2 other identifiers: 2019_452020-A01991-38
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 7

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.

Conditions

Obesity; NASH - Nonalcoholic Steatohepatitis

Keywords

NAFL; NASH screening; metabolic syndrome; Diagnostic Biomarker; non-invasive biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score

  Baseline

• Assessment of the correlation between the LLIFT score and the NAS score

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• RHU PreciNASH Task 1.4: collaborator
• Région Nord-Pas de Calais, France: collaborator

Study Sites (7)

Chu Amiens Picardie

Amiens, France

Location

CH ARRAS

Arras, France

Location

CH de Douai

Douai, France

Location

CH LENS

Lens, France

Location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

GHIRCL saint Philibert

Lomme, France

Location

Ch Valenciennes

Valenciennes, France

Location

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Guillaume Lassailly, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 5, 2020
• Study Start: February 16, 2021
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (7)