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

Prior treatment

• 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
• Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.

Other illness

• History of known HIV infection
• History of type 1 diabetes

Lab values

• 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.

Other

• \- 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:
• 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
• 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,

• 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.