An interventional study of atorvastatin and lifestyle counseling in Non Alcoholic Fatty Liver Disease, sponsored by Sheba Medical Center. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-27.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and 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:
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Exclusion Criteria:
statin therapy (atorvastatin 20 mg/d) for 6 months
Drug: atorvastatin
follow up group with no intervention
lifestyle modification by dietician counseling and follow-up
Behavioral: lifestyle counseling
atorvastatin 20 mg per day for 6 months
Also known as: Atorvastatin Teva, Lipitor, Litorva
lifestyle modification by dietician counseling and follow up
Change from baseline in liver steatosis at 6 months
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver steatosis and fibrosis. Liver steatosis will be assessed by sonographic liver fat quantification (hepatorenal sonographic index.
Time frame: baseline, 6 months and 12 months
change from baseline in liver fibrosis at 6 months
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver fibrosis. Liver fibrosis will be assessed by Real-Time shear wave elastography.
Time frame: baseline, 6 months and 12 months
endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients
measurement of endothelial function in NAFLD patients and finding the correlation between the degree of endothelial dysfunction and the severity of fatty liver disease. Endothelial function will be assessed by brachial artery flow-mediated (FMD) measurement at diagnosis and after 6 and 12 months. The severity of fatty liver disease will be assessed by liver elastography and sonographic liver fat quantification
Time frame: 12 months
relationship between blood parameters and liver steatosis and fibrosis
levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, Tumor necrosis factor alpha and ceruloplasmin and their correlation with liver steatosis and fibrosis
Time frame: 12 months
relationship between blood parameters and endothelial function
levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, tumor necrosis factor alpha and ceruloplasmin and their correlation with endothelial function
Time frame: at diagnosis and after 6 months and 12 months
change from baseline in endothelial function at 6 months
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on endothelial function. Endothelial function will be assessed by flow mediated dilatation (FMD) of brachial artery.
Time frame: at diagnosis 6 months and 12 months
This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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