NCT04435054Completed
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1000 (actual)
- First submitted
- 15 Jun 2020
- Start date
- 28 Oct 2020
- Primary completion date
- 28 Oct 2023
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04435054
What you commit to
- Study type: Interventional
- Participants enrolled: 1000
- From 28 Oct 2020 to the primary completion date, 28 Oct 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
Other illness
- Evidence of other causes of chronic liver disease:
- History of known HIV infection
- History of type 1 diabete
Other
- 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
- 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,
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hopital Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.