Status:
COMPLETED
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidel...
Eligibility Criteria
Inclusion
- Patient aged between 40 and 80 years old,
- Patients with diagnosis of T2DM\* or obesity (defined according to World Health Organization as a BMI≥ 30 kg/m2)
- 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
- Evidence of other causes of chronic liver disease:
- 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 diabete
- BMI ≥ 40 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 :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04435054
Start Date
October 28 2020
End Date
September 11 2024
Last Update
December 19 2025
Active Locations (3)
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1
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, France
2
CHU de Nantes
Nantes, France
3
Hôpital Lyon Sud
Pierre-Bénite, France