Skip to main content
OpenTrials
Completed

NCT Number: NCT04435054

Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.

Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Fibrosis Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged between 40 and 80 years old,
  • Patients with diagnosis of T2DM* or obesity (defined according to World Health Organization as a BMI≥ 30 kg/m2)
  • Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines.
  • Patient who agrees to be included in the study and who signs the informed consent form,
  • Patient affiliated to a healthcare insurance plan.

Exclusion criteria

  • Evidence of other causes of chronic liver disease:
  • History of ingestion of medications known to produce steatosis in the previous 6 months.
  • Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
  • Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any times in the last 10 years
  • The subject is a pregnant or nursing female
  • Life expectancy less than 5 years
  • History of known HIV infection
  • History of type 1 diabete
  • BMI ≥ 40 kg/m2
  • Mentally unbalanced patients, under supervision or guardianship,
  • Patient deprived of liberty,
  • Patient who does not understand French/ is unable to give consent,
  • Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.

Treatment and study plan

Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.

Diagnostic Test

Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD

Non-invasive imaging:

  • Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.

Primary outcomes

  1. Presence of individual F0 to F4 stage of fibrosis

    Time frame: 6 months

    The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.

Secondary outcomes

  1. Fibroscan

    Time frame: 6 months

    The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters

Acronym: NAFLD-CARE

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 17, 2020
Registry last updated
Dec 19, 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.

Related clinical trials

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