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"

Last updated: January 26, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Liver Disease

Treatment

N/A

Clinical Study ID

NCT04616664
2019_45
2020-A01991-38
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 increasedhepatic enzymes
  • Indication of NAFLD evaluation
  • Patients written consent
  • Affiliated to a social insurance

Exclusion

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 stentwithin 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 Design

Total Participants: 1027
Study Start date:
February 16, 2021
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Chu Amiens Picardie

    Amiens,
    France

    Site Not Available

  • CH ARRAS

    Arras,
    France

    Site Not Available

  • CH de Douai

    Douai,
    France

    Active - Recruiting

  • CH LENS

    Lens,
    France

    Site Not Available

  • Hop Claude Huriez Chu Lille

    Lille, 59037
    France

    Active - Recruiting

  • GHIRCL saint Philibert

    Lomme,
    France

    Active - Recruiting

  • Ch Valenciennes

    Valenciennes,
    France

    Site Not Available

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