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"

University Hospital, Lille

Status: Enrolling

Conditions: Obesity; NASH - Nonalcoholic Steatohepatitis

Study type: Observational

Funder types: Other

Identifiers

NCT04616664

2019_45

2020-A01991-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,027 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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