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"

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens Picardie, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Baseline

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

Secondary outcomes

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

Time frame: Baseline

The variables constituting the algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,..), genetic polymorphism.
Assessment of the correlation between the LLIFT score and the NAS score

Time frame: Baseline

The NAS score is a stratification based on steatosis, ballooning and lobular inflammation.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

RHU PreciNASH Task 1.4
Région Nord-Pas de Calais, France

Registry information

Acronym: LLIFT

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Nov 5, 2020
Registry last updated: Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting