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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04616664

Acronym

LLIFT

Enrollment

158

Registered

2020-11-05

Start date

2021-02-16

Completion date

2024-01-17

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH - Nonalcoholic Steatohepatitis, Obesity

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score	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	Baseline	The NAS score is a stratification based on steatosis, ballooning and lobular inflammation.

Countries

France

Outcome results