Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment

Sheba Medical Center

Status: Withdrawn

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Drug: atorvastatin; Behavioral: lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01987310

SHEBA-13-0694-ZBE-CTIL

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Statin

Active Comparator group

Description:

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

Treatment:

Drug: atorvastatin

usual care

No Intervention group

Description:

follow up group with no intervention

lifestyle counseling

Active Comparator group

Description:

lifestyle modification by dietician counseling and follow-up

Treatment:

Behavioral: lifestyle counseling