Clinical trial NCT01987310: Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
Official title: Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: non alcoholic fatty liver disease
endothelial function
liver steatosis
liver fibrosis
statin treatment
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* subjects willing to comply with study requirements and have signed an informed consent form
* fatty liver per abdominal ultrasound or liver biopsy

Exclusion Criteria:

* alcohol drinking \>140g/week
* presence of hepatitis B or C or HIV
* known liver disease other than fatty liver
* usage of drugs known to cause liver steatosis
* subjects with known allergies or hypersensitivity to statins
* subjects with known cardiovascular/cerebrovascular disease
* subjects with known dyslipidemia requiring drug treatment
* subjects with diabetes mellitus
* history of drug or alcohol abuse
* refusal to sig the informed consent form

Primary outcomes:
measure: Change from baseline in liver steatosis at 6 months
timeFrame: baseline, 6 months and 12 months
measure: change from baseline in liver fibrosis at 6 months
timeFrame: baseline, 6 months and 12 months
Secondary outcomes:
measure: endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients
timeFrame: 12 months
measure: relationship between blood parameters and liver steatosis and fibrosis
timeFrame: 12 months
measure: relationship between blood parameters and endothelial function
timeFrame: at diagnosis and after 6 months and 12 months
measure: change from baseline in endothelial function at 6 months
timeFrame: at diagnosis 6 months and 12 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center, Ramat Gan, Israel
name: Ziv Ben-Ari, MD
role: PRINCIPAL_INVESTIGATOR
References: