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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01617772
First received: June 8, 2012
Last updated: April 30, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Non-alcoholic Steatohepatitis Drug: Atorvastatin Drug: L-Carnitine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

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


Secondary Outcome Measures:
  • improvement in liver enzyme levels [ Time Frame: 2 years ]
  • Adverse drug events [ Time Frame: 2 years ]

Estimated Enrollment: 440
Actual Study Start Date: January 1, 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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 7.9 kp
  • pregnancy, lactation
  • Drug addiction
  • Reynolds Risk Score > 10%
  • Not consenting to the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617772

Contacts
Contact: Shahin Merat, Professor +98 917 117 3966 merat@tums.ac.ir
Contact: Reza Malekzadeh, Professor +98 912 111 4139 malek@ams.ac.ir

Locations
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    shahin.merat@gmail.com   
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Reza Malekzadeh, MD Tehran University of Medical Sciences
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01617772     History of Changes
Other Study ID Numbers: DDRI/90.10
Study First Received: June 8, 2012
Last Updated: April 30, 2017

Keywords provided by Tehran University of Medical Sciences:
Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017