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Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis (NALCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01617772
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : May 11, 2018
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: Atorvastatin Drug: L-Carnitine Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Atorvastatin
20mg atorvastatin daily
Drug: Atorvastatin
Atorvastatin 20 mg

Experimental: Carnitine
1000mg L-carnitine daily
Drug: L-Carnitine
1000mg L-carnitine

Experimental: Atoral
1000mg L-carnitine and 20mg atorvastatin
Drug: Atorvastatin
Atorvastatin 20 mg

Drug: L-Carnitine
1000mg L-carnitine

Placebo Comparator: Placebo
Identically looking placebo
Drug: Placebo
Identically looking placebo

Primary Outcome Measures :
  1. improvement in liver stiffness [ Time Frame: 2 years ]
    As measured by Fibroscan

Secondary Outcome Measures :
  1. improvement in liver enzyme levels [ Time Frame: 2 years ]
    Difference between last and first measurements

  2. Adverse drug events [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01617772

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Contact: Shahin Merat, Professor +98 917 117 3966
Contact: Reza Malekzadeh, Professor +98 912 111 4139

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Iran, Islamic Republic of
Pars Cohort Center Active, not recruiting
Shiraz, Fars, Iran, Islamic Republic of
Masoud Clinic Recruiting
Tehran, Iran, Islamic Republic of, 14117
Contact: Shahin Merat    +989171173966   
Sponsors and Collaborators
Tehran University of Medical Sciences
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Study Chair: Reza Malekzadeh, MD Tehran University of Medical Sciences

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Responsible Party: Tehran University of Medical Sciences Identifier: NCT01617772     History of Changes
Other Study ID Numbers: 90-03-37-15428
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Tehran University of Medical Sciences:
Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors