Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes

Recruiting now · Not applicable

Conditions studied: Metabolic Dysfunction-Associated Liver Disease

In brief

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 facts

Study ID

NCT06567990

Run by

Hospices Civils de Lyon

People needed

500

Starts

2024-09-25

Expected to finish

2027-05-25

Last updated by the study team

2026-01-28

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition — Dijon, France (enrolling)
• Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital — Lyon, France (enrolling)
• Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut — Nantes, France (enrolling)
• Service d'Endocrinologie, Diabète et nutrition — Pierre-Bénite, France (enrolling)

Full record on ClinicalTrials.gov

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