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

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

Conditions

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Non Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Statin

statin therapy (atorvastatin 20 mg/d) for 6 months

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

atorvastatin 20 mg per day for 6 months

usual care

follow up group with no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

lifestyle counseling

lifestyle modification by dietician counseling and follow-up

Group Type ACTIVE_COMPARATOR

lifestyle counseling

Intervention Type BEHAVIORAL

lifestyle modification by dietician counseling and follow up

Interventions

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atorvastatin

atorvastatin 20 mg per day for 6 months

Intervention Type DRUG

lifestyle counseling

lifestyle modification by dietician counseling and follow up

Intervention Type BEHAVIORAL

Other Intervention Names

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Atorvastatin Teva, Lipitor, Litorva

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Ziv Ben-Ari MD

Head of Disease Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-13-0694-ZBE-CTIL

Identifier Type: -

Identifier Source: org_study_id

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