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

Primary Purpose

Non-alcoholic Steatohepatitis

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
L-Carnitine
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis focused on measuring Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pars Cohort Center
  • Masoud ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Carnitine

Atoral

Placebo

Arm Description

20mg atorvastatin daily

1000mg L-carnitine daily

1000mg L-carnitine and 20mg atorvastatin

Identically looking placebo

Outcomes

Primary Outcome Measures

improvement in liver stiffness
As measured by Fibroscan

Secondary Outcome Measures

improvement in liver enzyme levels
Difference between last and first measurements
Adverse drug events
questionnaire

Full Information

First Posted
June 8, 2012
Last Updated
May 5, 2018
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01617772
Brief Title
Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis
Acronym
NALCAT
Official Title
Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis
Keywords
Non-alcoholic steatohepatitis, Atorvastatin, L-Carnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
20mg atorvastatin daily
Arm Title
Carnitine
Arm Type
Experimental
Arm Description
1000mg L-carnitine daily
Arm Title
Atoral
Arm Type
Experimental
Arm Description
1000mg L-carnitine and 20mg atorvastatin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identically looking placebo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 20 mg
Intervention Type
Drug
Intervention Name(s)
L-Carnitine
Intervention Description
1000mg L-carnitine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identically looking placebo
Primary Outcome Measure Information:
Title
improvement in liver stiffness
Description
As measured by Fibroscan
Time Frame
2 years
Secondary Outcome Measure Information:
Title
improvement in liver enzyme levels
Description
Difference between last and first measurements
Time Frame
2 years
Title
Adverse drug events
Description
questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NASH diagnosed on the basis of the following criteria: Imaging techniques showing evidence of hepatic steatosis 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahin Merat, Professor
Phone
+98 917 117 3966
Email
merat@tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Malekzadeh, Professor
Phone
+98 912 111 4139
Email
malek@ams.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Malekzadeh, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Pars Cohort Center
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Active, not recruiting
Facility Name
Masoud Clinic
City
Tehran
ZIP/Postal Code
14117
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahin Merat
Phone
+989171173966
Email
shahin.merat@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

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