Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
NCT ID: NCT01987310
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-12-31
2015-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Statin
statin therapy (atorvastatin 20 mg/d) for 6 months
atorvastatin
atorvastatin 20 mg per day for 6 months
usual care
follow up group with no intervention
No interventions assigned to this group
lifestyle counseling
lifestyle modification by dietician counseling and follow-up
lifestyle counseling
lifestyle modification by dietician counseling and follow up
Interventions
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atorvastatin
atorvastatin 20 mg per day for 6 months
lifestyle counseling
lifestyle modification by dietician counseling and follow up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* fatty liver per abdominal ultrasound or liver biopsy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof. Ziv Ben-Ari MD
Head of Disease Medical Center
Principal Investigators
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Ziv Ben-Ari, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center, Ramat Gan, Israel
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Other Identifiers
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SHEBA-13-0694-ZBE-CTIL
Identifier Type: -
Identifier Source: org_study_id
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