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

NCT01987310 | Withdrawn

• 1 other identifier: SHEBA-13-0694-ZBE-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

non alcoholic fatty liver disease; endothelial function; liver steatosis; liver fibrosis; statin treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients

  12 months

• relationship between blood parameters and liver steatosis and fibrosis

  12 months

• relationship between blood parameters and endothelial function

  at diagnosis and after 6 months and 12 months

• change from baseline in endothelial function at 6 months

  at diagnosis 6 months and 12 months

Study Arms (3)

Statin

ACTIVE COMPARATOR

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

Drug: atorvastatin

usual care

NO INTERVENTION

follow up group with no intervention

lifestyle counseling

ACTIVE COMPARATOR

lifestyle modification by dietician counseling and follow-up

Behavioral: lifestyle counseling

Interventions

atorvastatin DRUG

atorvastatin 20 mg per day for 6 months

Also known as: Atorvastatin Teva, Lipitor, Litorva

Statin

lifestyle counseling BEHAVIORAL

lifestyle modification by dietician counseling and follow up

lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ziv Ben-Ari, MD

  Sheba Medical Center, Ramat Gan, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Disease Medical Center

Study Record Dates

• First Submitted: October 27, 2013
• First Posted: November 19, 2013
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

IL (1)