Type 2 diabetes with fatty liver: new markers to track disease progression and outcomes
Official title: Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Run by Hospices Civils de Lyon · NCT06567990 · Data updated 2026-11-12
This project will test whether baseline non‑invasive blood and liver scan markers can tell which people with type 2 diabetes and fatty liver will have worsening liver disease or related complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Dijon and 3 other locations) |
| Status | Recruiting |
| Started | September 25, 2024 |
| Main results expected | May 25, 2027 |
| Study ends | May 25, 2027 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT06567990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40–80 with type 2 diabetes, ultrasound‑confirmed hepatic steatosis, health insurance coverage, and willing to sign informed consent are ideal candidates.
✕Probably not a fit
People with established cirrhosis (histologic F4 or imaging‑proven cirrhosis), other chronic liver diseases, or without ultrasound‑proven steatosis are unlikely to benefit from this screening‑focused project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective multi‑center project enrolls adults with type 2 diabetes and ultrasound‑proven hepatic steatosis and records baseline non‑invasive tests such as FIB‑4 and liver stiffness measurement. Participants will be followed over time to see who shows progression of metabolic dysfunction‑associated liver disease (MASLD) and who develops related clinical outcomes. The study aims to link baseline biomarker profiles to later liver fibrosis progression and diabetes complications. Findings will inform how non‑invasive tests can be used in routine diabetes care to stratify risk.
Why it matters
Potential benefit: If successful, clinicians could identify high‑risk patients earlier and personalize monitoring or treatment to reduce liver‑related complications.
How similar studies have gone: Prior studies and guidelines support using FIB‑4 and liver stiffness measurement for screening, but prospective longitudinal data linking baseline non‑invasive tests to MASLD progression in type 2 diabetes are limited, so this approach is partly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: \- 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 : 1. Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). 2. Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab). 3. 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. 4. 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. 5. Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. 6. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. 7. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. 8. Drug-induced liver disease as defined on the basis of typical exposure and history. 9. 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.
Where it's running
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Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Dijon, France Recruiting -
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
Lyon, France Recruiting -
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
Nantes, France Recruiting -
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, France Recruiting
Study contacts
- Study coordinator: Cyrielle CAUSSY, Pr
- Email: cyrielle.caussy@chu-lyon.fr
- Phone: 4 78 86 44 48
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.