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

NCT02463318 | Completed DMC

• 1 other identifier: 91-01-30-17019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Oxidative Stress

Keywords

Multiple sclerosis; SIRT1; MnSOD; Catalase; Oxidative stress; Antioxidant enzyme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• SIRT1 enzyme activity assay

  Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Study Arms (2)

Multiple slerosis

EXPERIMENTAL

Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.

Drug: Melatonin

Healthy subjects

EXPERIMENTAL

Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

Drug: Melatonin; Other: Hydrogen peroxide

Interventions

Melatonin DRUG

Melatonin is used for healthy subjects and multiple sclerosis patients

Also known as: N-acetyl-5-methoxy tryptamine

Healthy subjects; Multiple slerosis

Hydrogen peroxide OTHER

Hydrogen peroxide is only used for healthy subjects

Healthy subjects

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Solaleh Emamgholipour

Tehran, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Melatonin; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Officials

• Mohammad Ali Sahraian, Neurologist

  Tehran University of Medical Sciences

  STUDY DIRECTOR

• Solaleh Emamgholipour, PhD Student

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 2, 2017

Record last verified: 2015-06

Locations

IR (1)