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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 500

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Assessment of clinical events associated with the natural history of MASLD and T2D for both cohorts

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