Non-Alcoholic Fatty Liver DiseaseNAFLD-CARENCT04435054
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
A study testing Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. in people with Non-Alcoholic Fatty Liver Disease, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Oct 2020to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon
CHU de Nantes
Nantes
Hôpital Lyon Sud
Pierre-Bénite
About this study
Official 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
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
- Keywords
- NAFLD, Type 2 diabete, Obesity, Advanced fibrosis, Cirrhosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive tests | Other | Not described Receives: Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of individual F0 to F4 stage of fibrosis
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.
Measured: 6 months
Secondary outcomes (1)
Fibroscan
The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start28 Oct 2020
- Primary completion28 Oct 2023
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrielle CAUSSY, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435054
- Sponsor's protocol ID
- 69HCL20_0033
- Acronym
- NAFLD-CARE
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caussy C, Verges B, Leleu D, Duvillard L, Subtil F, Abichou-Klich A, Hervieu V, Milot L, Segrestin B, Bin S, Rouland A, Delaunay D, Morcel P, Hadjadj S, Primot C, Petit JM, Charriere S, Moulin P, Levrero M, Cariou B, Disse E. Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study. Diabetes Care. 2025 Jun 1;48(6):877-886. doi: 10.2337/dc24-2075.
PubMed 39887699
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04435054
- Acronym / sponsor ID
- NAFLD-CARE / 69HCL20_0033
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, Type 2 diabete, Obesity, Advanced fibrosis, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non invasive tests | Other | Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.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. | Diagnostic test | Non invasive tests |
Primary outcome
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.
1 secondary outcome
Fibroscan
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 39887699Caussy C, Verges B, Leleu D, Duvillard L, Subtil F, Abichou-Klich A, Hervieu V, Milot L, Segrestin B, Bin S, Rouland A, Delaunay D, Morcel P, Hadjadj S, Primot C, Petit JM, Charriere S, Moulin P, Levrero M, Cariou B, Disse E. Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study. Diabetes Care. 2025 Jun 1;48(6):877-886. doi: 10.2337/dc24-2075.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrielle CAUSSY, MD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. in people with Non-Alcoholic Fatty Liver Disease, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of individual F0 to F4 stage of fibrosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.