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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Oxidative Stress
• Interventions: Drug: Melatonin; Other: Hydrogen peroxide

• Registration Number: NCT02463318
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Study Completion: 2015-09
• Last Update Submitted: 2017-04-30
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple slerosis	Melatonin	Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.
Healthy subjects	Melatonin	Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment
Healthy subjects	Hydrogen peroxide	Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SIRT1 enzyme activity assay	Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
MnSOD enzyme activity assay	Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Catalse enzyme activity assay	Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Trial Locations

Locations (1)

Solaleh Emamgholipour; 🇮🇷 Tehran, Iran, Islamic Republic of