Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

Non-alcoholic Steatohepatitis Clinical Trial

— NALCAT  

Official title:

Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01617772
• Other study ID #: 90-03-37-15428
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Tehran University of Medical Sciences
• Contact: Shahin Merat, Professor
• Phone: +98 917 117 3966
• Email: merat[@]tums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

Description:

Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of disease ranging from steatosis to steatohepatitis (nonalcoholic steatohepatitis, NASH) to cirrhosis. Statins are competitive inhibitors of Hydroxymethylglutaryl-CoA reductase, the rate-limiting step in cholesterol biosynthesis. They occupy a portion of the binding site of Hydroxymethylglutaryl-CoA, blocking access of this substrate to the active site on the enzyme. A reduction in intrahepatic cholesterol leads to an increase in LDL receptor turnover that results from an enhanced rate of hepatic LDL receptor cycling. On the other hand recent studies have implicated several important cellular processes and signaling pathways that are affected by abnormal lipid metabolism, resulting in specific biochemical, histological, and clinical changes associated with NAFLD.

Maybe statins, as lipid lowering agents, and through their effect in reduction of intrahepatic cholesterol, can affect the abnormal lipid metabolism in NASH.

L- carnitine, can improve the outcome of NASH, because it reduces lipid levels, limits oxidative stress, and modulates inflammatory responses . It performs a number of essential intracellular and metabolic functions, such as fatty acid transport, detoxification of potentially toxic metabolites, regulation of the mitochondrial acyl-CoA / CoA ratio, and stabilization of cell membranes. It has a pivotal role in the transport of long chain fatty acids across the inner mitochondrial membrane.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• NASH diagnosed on the basis of the following criteria:

1. Imaging techniques showing evidence of hepatic steatosis

2. Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.

Exclusion Criteria:

• Patients with hepatitis B or C

• alanine transaminase > 300 IU/L

• Participants presenting one or more causes commonly associated with secondary NAFLD (drugs, surgical procedures, environmental toxins, or total parenteral nutrition)

• Alcohol ingestion greater than 40 gr per week

• Abnormal Lipid profile (TG>500 , LDL>160)

• Patients with hypertension, diabetes mellitus, coronary heart disease

• Fibroscan score more than 14 kp

• pregnancy, lactation

• Drug addiction

• Reynolds Risk Score > 10%

• Not consenting to the study

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• Atorvastatin
Atorvastatin 20 mg
• L-Carnitine
1000mg L-carnitine
• Placebo
Identically looking placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Pars Cohort Center	Shiraz	Fars
Iran, Islamic Republic of	Masoud Clinic	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in liver stiffness	As measured by Fibroscan	2 years
Secondary	improvement in liver enzyme levels	Difference between last and first measurements	2 years
Secondary	Adverse drug events	questionnaire	2 years