Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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). 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.
Eligibility
Primary outcome measure(s)
- 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). — 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
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Hospices Civils de Lyon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06567990 on ClinicalTrials.gov ↗ ← All trials in France