Status:
COMPLETED
Lysosomal Acid Lipase Activity in Nonalcoholic Fatty Liver Disease
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is a multifactorial disease affecting a quarter of the world population. Pathological accumulation of fat, into the hepatocytes, is the first hit and is due t...
Eligibility Criteria
Inclusion
- Caucasian Italian subjects
- age \> 18 and \< 70 years
- non-cirrhotic NAFLD
Exclusion
- any malignant disease during the last 5 years
- any inflammatory or autoimmune disease
- corticosteroids for systemic use
- any medication potentially affecting body weight or body composition
- syndromic obesity
- renal failure (GFR\<90 ml/min)
- heart failure (NYHA classes II-IV)
- any type liver disease rather than NAFLD
- alcohol intake \>140g/ week for men and 70g/ week for women
- participation in a reducing- weight program in the last 3 months
- cholestyramine during the last 6 months before enrollment
- previous cholecystectomy
- gallbladder disease
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT05419765
Start Date
March 1 2022
End Date
March 31 2023
Last Update
December 9 2024
Active Locations (1)
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1
Department of Translational and Precision Medicine, Sapienza University of Rome, Umberto I Hospital
Rome, Rome, Italy, 00185