Status:
NOT_YET_RECRUITING
Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Metabolic Dysfunction-Associated Liver Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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). T...
Detailed Description
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). T...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06567990
Start Date
September 15 2024
End Date
November 15 2026
Last Update
August 23 2024
Active Locations (1)
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1
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, France, 69495