Protocol summary

Summary
The aim of this study is to investigate the Serum levels of microRNA-16, microRNA-21, microRNA-217 and effects of L-carnitine on their levels, Tumor Necrosis Factor-α, Tumor Growth Factor-β cytokines, Malondialdehyde and C-Reactive Protein in Nonalcoholic Steatohepatitis patients under weight loss regimen. Inclusion criteria: age between 18-65 years; BMI≥25 kg/m2, under weight loss regimen; ALT≥1.5 fold norma;l Sonography showing Nonalcoholic Steatohepatitis, Exclusion criteria: not willing to collaborate;viral hepatitis; taking Insulin ;blood lipid-lowering agents; Antiinflammatory drugs(stroid and non stroid)and antioxidant supplement; smoking cigarettes. In this parallel randomized controlled trial, 92 men and women with NASH. will be recruited from nutrition clinic of Imam Reza hospital of Mashhad University of Medical Science. Blood samples will be obtained after an overnight fast before and after the study. Plasma miRNA will be extracted with Mirvana kit and then Real time PCR will be done. Other variables also will be measured. 3-days 24-recalls will be obtained at first and at the end of the study. Intervention group receives 2000 mg of L-carnitine as 2 vials and other group receives 2 placebo vials,before the meals, for 12 weeks. agents ,Antiinflammatory drugs(stroid and non stroid)and antioxidant supplement ,smoking cigarettes. Blood samples will be obtained after an overnight fast before and after the study.Plasma miRNA will be extracted with Mirvana kit and then Real time PCR will be done. TNF-α , TGF-β cytokines, Malondialdehyde and CRP also will be measured. 3-days 24-recalls will be obtained at first and at the end of the study. Intervention group receives 2000 mg of L-carnitine as 2 vials and other group receives 2 placebo vials,before the meals, for 12 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212052602N8
Registration date: 2013-02-04, 1391/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-04, 1391/11/16
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs of Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Serum levels of miRNA-16, miRNA-21, miRNA-217 and effects of L-carnitine on their levels , TNF-α , TGF-β cytokines, Malondialdehyde and CRP in Nonalcoholic Steatohepatitis (NASH) patients under weight loss regimen
Public title
Effects of L-carnitine on genetic, inflammation and antioxidant factors in Nonalcoholic Steatohepatitis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age between 18-65 years; BMI≥25 kg/m2, under weight loss regimen ; ALT≥1.5 fold normal; Sonography showing Nonalcoholic Steatohepatitis ; Exclusion criteria: not willing toCollaborate; viral hepatitis; taking Insulin; blood lipid-lowering agents;Antiinflammatory drugs(stroid and non stroid) and antioxidant supplements; smoking cigarettes.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of public Health,Tehran University of Medical Sciences
Street address
School of public Health, Alvand street,Argentina Square
City
Tehran
Postal code
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
91-03-161-19463-69987

Health conditions studied

1

Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.9
ICD-10 code description
Nonalcoholic steatohepatitis( NASH)

Primary outcomes

1

Description
TNF-α
Timepoint
At first of the study and 12th week
Method of measurement
labratory kit

2

Description
TGF-β
Timepoint
At first of the study and 12th week
Method of measurement
Sandwich Elisa

3

Description
Malondialdehide
Timepoint
At first of the study and 12th week
Method of measurement
Sandwich Elisa

4

Description
CRP
Timepoint
At first of the study and 12th week
Method of measurement
labratory kit

5

Description
miRNA-16
Timepoint
At first of the study and 12th week
Method of measurement
RT-PCR

6

Description
miRNA-21
Timepoint
At first of the study and 12th week
Method of measurement
RT-PCR

7

Description
miRNA-217
Timepoint
At first of the study and 12th week
Method of measurement
RT-PCR

Secondary outcomes

empty

Intervention groups

1

Description
. Intervention group receives 2000 mg of L-carnitine as 2 vials,before the meals, for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group receives 2000 mg of Placebo as 2 vials,before the meals, for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition clinic of Imam Reza hospital
Full name of responsible person
Dr. Mohsen Nematy
Street address
School Of Medicine, Ferdosi University of Medical Sciences, Azadi Square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Vice Chancellor for Research of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of public Health,Tehran University of Medical Sciences
Full name of responsible person
Dr.Shirin Amiri Moghaddam
Position
MD/Ph.D Student
Other areas of specialty/work
Street address
School of public Health, Alvand street, No 60,Argentina Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
amiri_shirin14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of public Health,Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahryar Eghtesadi
Position
Professor/Ph.D
Other areas of specialty/work
Street address
School of Public Health, No 60, Alvand Street, Argentina Square
City
Tehrane
Postal code
1516846514
Phone
+98 21 8877 9118 ext. 273
Fax
+98 21 8877 9487
Email
sh-eghtesadi@tums.ac.ir, egtesadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health,Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahryar Eghtesadi.
Position
Professor/Ph.D
Other areas of specialty/work
Street address
School of Public Health, Alvand Street No 60, Argentina Square
City
Tehran
Postal code
1516846514
Phone
+98 21 8877 9118 ext. 273
Fax
+98 21 8877 9487
Email
sh-eghtesadi@tums.ac.ir, egtesadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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