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

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01987310
• Other study ID #: SHEBA-13-0694-ZBE-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2013
• Last updated: April 25, 2017
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• atorvastatin
atorvastatin 20 mg per day for 6 months

Behavioral:
• lifestyle counseling
lifestyle modification by dietician counseling and follow up

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 6 months and 12 months
Primary	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.	baseline, 6 months and 12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	at diagnosis and after 6 months and 12 months
Secondary	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.	at diagnosis 6 months and 12 months