Non Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
The aim of the current study is to evaluate the association of fatty liver severity and endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the impact of statin treatment compared to usual care or life style modification on endothelial function, liver steatosis and fibrosis.
The study cohort will include 150 patients with fatty liver per ultrasound or histology. The
patients will be divided randomly to one of three arms: follow up group, lifestyle
modification group, and statins therapy (Atorvastatin 20mg/d for 6 months). at screening,
after 6 months (end of treatment), and 12 months the patients will undergo:
1. complete physical examination
2. blood pressure measurement
3. assessment of height and weight, body mass index and waist circumference
4. blood samples for complete blood count, fasting plasma glucose, fasting plasma insulin,
lipid profile, liver enzymes, albumin, bilirubin, Prothrombin time (PT INR), Hemoglobin
A1c, ferritin, adiponectin, C-reactive protein, Tumor necrosis factor alpha,
Lipoprotein-phospholipase A2, Apolipoproteins B100, A1, C3, C4, ceruloplasmin
5. Liver elastography and sonographic liver fat quantification
6. Brachial artery flow-mediated dilatation (FMD) measurement
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