Metabolic Dysfunction-Associated Liver DiseaseDIATONICNCT06567990
Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
A study testing Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D. in people with Metabolic Dysfunction-Associated Liver Disease, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Liver Disease
- What is being tested?
- Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Sep 2024to 25 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with T2D and meeting the other inclusion criteria of the NAFLD-Care study:
- Patient aged between 40 and 80 years old,
- 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
- Participants with a diagnosis of cirrhosis defined by a liver biopsy with histological stage of fibrosis F4 or a proven diagnosis of cirrhosis by magnetic resonance imaging.
- The main non-inclusion criteria for the NAFLD-CARE study are:
- Evidence of other causes of chronic liver disease :
- Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
- Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
- Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
Show all 24Show fewer
- Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
- Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
- Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
- Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
- Drug-induced liver disease as defined on the basis of typical exposure and history.
- Bile duct obstruction as shown by imaging studies.
- 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 diabetes
- BMI ≥ 45 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Dijon, BP 1542- 14
ROULAND Alexia, MD, 3 80 29 34 53 ext. +33, alexia.rouland@chu-dijon.fr
- Recruiting
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
Lyon, 69677
CHARRIERE Sybil, MD, 4 72 68 13 31 ext. +33, Sybil.charriere@chu-lyon.fr
- Recruiting
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
Nantes, 44093
CARIOU Bertrand, MD, 2 40 08 33 33 ext. +33, bertrand.cariou@univ-nantes.fr
- Recruiting
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, 69495
Cyrielle CAUSSY, MD, 4 78 86 44 48, cyrielle.caussy@chu-lyon.fr
Dominique DELAUNAY, Dr, 4.72.11.00.64 ext. +33, Dominique.delaunay@chu-lyon.fr
About this study
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM).The main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.
Read the detailed description
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM). Hence, these Non-Invasive Tests (NITs) are expected to be integrated in the management of T2DM in a near future. Indeed diabetologists are becoming more aware of the need for liver assessment in patients with T2DM recently reinforced by recent clear recommendations supporting the use of non-invasive test (NITs) such as LSM for the detection of liver fibrosis. Several studies indicate that MASLD increases the risk of T2DM complications. However, there are very limited data and no prospective longitudinal data assessing the progression of MASLD and relevant clinical outcomes in T2DM patients included in liver screening using these NITs. This provides a unique opportunity to better stratify T2DM and to understand the heterogeneity among patients with T2DM by defining patient's profiles linked the progression of MASLD and relevant clinical outcomes.
Therefore, the main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.
- Being tested
- Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.
- Keywords
- MASLD, Type 2 diabetes, Obesity, Advanced fibrosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.Diagnostic test
- Non-invasive blood biological tests = NAFLD Fibrosis Score, FIB-4 score, FNI score, Agile3+ score, FASTscore, ELF, Fibrotest, Fibrometer if performed in clinical care
- Non-invasive imaging = Transient elastography (FibroScan), Questionnaire assessing alcohol consumption
| Study group | Role | What they receive |
|---|---|---|
| Patients with T2D and MASLD without advanced fibrosis (AF) (COHORT A) | Other | Patients with T2D and MASLD without advanced fibrosis (AF) at baseline in the NAFLD-Care study. Receives: Diagnostic Test: Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D. |
| Patients with T2D and MASLD, without diagnosis of cirrhosis (COHORT B) | Other | Patients with T2D and MASLD with presence of advanced fibrosis (AF) and without cirrhosis at baseline in the NAFLD-Care study Receives: Diagnostic Test: Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of MASLD for T2D and MASLD patients without AF at baseline (cohort A) or progression to confirmed diagnosis of cirrhosis for T2D and MASLD patients with presence of AF at baseline and without cirrhosis (cohort B).
COHORT A = Composite outcome defined by either histological stage of fibrosis ≥ F3 if a liver biopsy is performed in clinical care or concordant patented Fibrotest≥ F3 and LSM≥ 8 kPa according to EASL guidelines or overt imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI COHORT B = Histological stage of fibrosis 4 or imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI
Measured: One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Secondary outcomes (1)
Assessment of clinical events associated with the natural history of MASLD and T2D for both cohorts
Occurrence of T2D COMPLICATIONS (retinopathy, neuropathy, nephropathy, diabetes foot ulcer ), CARDIOVASCULAR EVENTS (coronary artery disease, myocardial infarction, coronary revascularization, stroke, arteriopathy of the lower limbs), LIVER RELATED EVENTS (ascites, esophageal variceal bleeding or needed prophylactic treatment, liver transplantation, hepatocellular carcinoma), KIDNEY RELATED EVENTS (occurence or progression of diabetic nephropathy), DEATHS (all causes).
Measured: One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start25 Sep 2024
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-site, not randomized, national study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567990
- Sponsor's protocol ID
- 69HCL24_0022
- Acronym
- DIATONIC
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
- ClinicalTrials.gov ID
- NCT06567990
- Acronym / sponsor ID
- DIATONIC / 69HCL24_0022
- Keywords
- MASLD, Type 2 diabetes, Obesity, Advanced fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 23 Aug 2024 (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.
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM).The main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.
Detailed description
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM). Hence, these Non-Invasive Tests (NITs) are expected to be integrated in the management of T2DM in a near future. Indeed diabetologists are becoming more aware of the need for liver assessment in patients with T2DM recently reinforced by recent clear recommendations supporting the use of non-invasive test (NITs) such as LSM for the detection of liver fibrosis. Several studies indicate that MASLD increases the risk of T2DM complications. However, there are very limited data and no prospective longitudinal data assessing the progression of MASLD and relevant clinical outcomes in T2DM patients included in liver screening using these NITs. This provides a unique opportunity to better stratify T2DM and to understand the heterogeneity among patients with T2DM by defining patient's profiles linked the progression of MASLD and relevant clinical outcomes.
Therefore, the main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-site, not randomized, national study
| Arm | Type | Receives |
|---|---|---|
| Patients with T2D and MASLD without advanced fibrosis (AF) (COHORT A) | Other | Diagnostic Test: Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.Patients with T2D and MASLD without advanced fibrosis (AF) at baseline in the NAFLD-Care study. |
| Patients with T2D and MASLD, without diagnosis of cirrhosis (COHORT B) | Other | Diagnostic Test: Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.Patients with T2D and MASLD with presence of advanced fibrosis (AF) and without cirrhosis at baseline in the NAFLD-Care study |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with T2D and meeting the other inclusion criteria of the NAFLD-Care study:
- Patient aged between 40 and 80 years old,
- 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 (24 listed)
- Participants with a diagnosis of cirrhosis defined by a liver biopsy with histological stage of fibrosis F4 or a proven diagnosis of cirrhosis by magnetic resonance imaging.
- 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
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 test for the screening of MASLD-related advanced fibrosis in patients with T2D.* Non-invasive blood biological tests = NAFLD Fibrosis Score, FIB-4 score, FNI score, Agile3+ score, FASTscore, ELF, Fibrotest, Fibrometer if performed in clinical care * Non-invasive imaging = Transient elastography (FibroScan), Questionnaire assessing alcohol consumption | Diagnostic test | Patients with T2D and MASLD without advanced fibrosis (AF) (COHORT A), Patients with T2D and MASLD, without diagnosis of cirrhosis (COHORT B) |
Primary outcome
Progression of MASLD for T2D and MASLD patients without AF at baseline (cohort A) or progression to confirmed diagnosis of cirrhosis for T2D and MASLD patients with presence of AF at baseline and without cirrhosis (cohort B).
Time frame: One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
COHORT A = Composite outcome defined by either histological stage of fibrosis ≥ F3 if a liver biopsy is performed in clinical care or concordant patented Fibrotest≥ F3 and LSM≥ 8 kPa according to EASL guidelines or overt imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI COHORT B = Histological stage of fibrosis 4 or imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI
1 secondary outcome
Assessment of clinical events associated with the natural history of MASLD and T2D for both cohorts
Time frame: One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Metabolic Dysfunction-Associated Liver Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Enrolling by invitation
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
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.
4 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 test for the screening of MASLD-related advanced fibrosis in patients with T2D. in people with Metabolic Dysfunction-Associated Liver Disease, run by Hospices Civils de Lyon at 4 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 24 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrielle CAUSSY, Pr (4 78 86 44 48 ext. 33, cyrielle.caussy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of MASLD for T2D and MASLD patients without AF at baseline (cohort A) or progression to confirmed diagnosis of cirrhosis for T2D and MASLD patients with presence of AF at baseline and without cirrhosis (cohort B). (time frame: One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.