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Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Sponsor: Hospices Civils de Lyon
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.
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-09-25
Completion Date
2027-05-25
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
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
Locations (4)
Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Dijon, France
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
Lyon, France
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
Nantes, France
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, France