The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects

April 30, 2017 updated by: Tehran University of Medical Sciences
The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.

-

Exclusion Criteria:

  • The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple slerosis
Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.
Drug: Melatonin
Melatonin is used for healthy subjects and multiple sclerosis patients
Other Names:
  • N-acetyl-5-methoxy tryptamine
Experimental: Healthy subjects
Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment
Drug: Melatonin
Melatonin is used for healthy subjects and multiple sclerosis patients
Other Names:
  • N-acetyl-5-methoxy tryptamine
Other: Hydrogen peroxide
Hydrogen peroxide is only used for healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative gene expression by real-time PCR (polymerase chain reaction)
Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Secondary Outcome Measures

Outcome Measure
Time Frame
MnSOD enzyme activity assay
Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Catalse enzyme activity assay
Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
SIRT1 enzyme activity assay
Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Mohammad Ali Sahraian, Neurologist, Tehran University Of Medical Sciences
  • Principal Investigator: Solaleh Emamgholipour, PhD Student, Tehran University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 30, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91-01-30-17019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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