The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis

NCT06290453 | Not Yet Recruiting

• 1 other identifier: AOGR
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• • To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients.

  RNA extraction Reverse Transcription polymerase chain reaction (RT-PCR) analysis:

  1 month

Secondary Outcomes (1)

• To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients.

  1 month

Study Arms (2)

Multiple sclerosis patients (MS)

included 40 patients with newly discovered MS (duration of the disease is 3 years or less) and diagnosed according to the revised McDonald criteria. The patients will be recruited from the neurology department of Assiut University Hospital. MS patients will be further subdivided into two subgroups: 20 patients with RRMS and 20 patients with Progressive MS group.

Diagnostic Test: micro RNA 27- FLP1 gene expression; Diagnostic Test: The Expanded Disability Status Scale (EDSS); Diagnostic Test: Electrophysiological assessment:; Diagnostic Test: MRI examination MRI brain:

Control (C)

Group II: included 20 healthy individuals who will be age- and sex-matched as a control group, with no history of any neurological or autoimmune disease.

Diagnostic Test: micro RNA 27- FLP1 gene expression

Interventions

micro RNA 27- FLP1 gene expression DIAGNOSTIC_TEST

From each participant, 2 mL of blood will be drawn and store at 25-degree C. The expression of miRNA-27 and FLP1 gene will be measured using real time PCR. Relative expression values will be normalised to the housekeeping gene GAPDH. The comparative cycle threshold (Ct) approach will be used to measure the relative expression of miRNA 27 and FLP1 gene. Then, using the equation -ΔΔCT, the fold change of each gene will be determined

Control (C); Multiple sclerosis patients (MS)

The Expanded Disability Status Scale (EDSS) DIAGNOSTIC_TEST

The Expanded Disability Status Scale (EDSS) is a way of measuring how much someone is affected by their MS. Neurologists use it to monitor changes in the level of someone's disability over time. The EDSS has a range from 0 to 10. Zero points is normal neurological examination. 10 points shows the MS-related death cases. Patients with EDSS score up to 5 are fully ambulatory patients.

Multiple sclerosis patients (MS)

Electrophysiological assessment: DIAGNOSTIC_TEST

Electromyography and nerve conduction velocity will be performed for all MS patients.

Multiple sclerosis patients (MS)

MRI examination MRI brain: DIAGNOSTIC_TEST

will be done on all MS patients to detect the number, the site, and the enhancement of lesions

Multiple sclerosis patients (MS)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study subjects: 1. Inclusion criteria: 1. Patients diagnosed with MS based on the revised McDonald criteria. 2. Female patients will only be included. 3. 20- 45 years old. 4. Drug naïve. 2. Exclusion criteria: 1. Patients with other neurodegenerative and autoimmune disorders. 2. Pregnant females. 3. Co-existing chronic hypertension, diabetes, and epilepsy 4. Chronic renal or hepatic diseases

You may qualify if:

• Patients diagnosed with MS based on the revised McDonald criteria.
• Female patients will only be included.
• years old.
• Drug naïve.

You may not qualify if:

• \. Patients with other neurodegenerative and autoimmune disorders. 2. Pregnant females. 3. Co-existing chronic hypertension, diabetes, and epilepsy 4. chronic renal or hepatic diseases

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Chaly Y, Marinov AD, Oxburgh L, Bushnell DS, Hirsch R. FSTL1 promotes arthritis in mice by enhancing inflammatory cytokine/chemokine expression. Arthritis Rheum. 2012 Apr;64(4):1082-8. doi: 10.1002/art.33422. Epub 2011 Oct 17.

  PMID: 22006268 RESULT

• Chen L, Lu Q, Chen J, Feng R, Yang C. Upregulating miR-27a-3p inhibits cell proliferation and inflammation of rheumatoid arthritis synovial fibroblasts through targeting toll-like receptor 5. Exp Ther Med. 2021 Nov;22(5):1227. doi: 10.3892/etm.2021.10661. Epub 2021 Aug 27.

  PMID: 34539823 RESULT

• Mattiotti A, Prakash S, Barnett P, van den Hoff MJB. Follistatin-like 1 in development and human diseases. Cell Mol Life Sci. 2018 Jul;75(13):2339-2354. doi: 10.1007/s00018-018-2805-0. Epub 2018 Mar 29.

  PMID: 29594389 RESULT

• Pachner AR. The Neuroimmunology of Multiple Sclerosis: Fictions and Facts. Front Neurol. 2022 Feb 7;12:796378. doi: 10.3389/fneur.2021.796378. eCollection 2021.

  PMID: 35197914 RESULT

• Shi DL, Shi GR, Xie J, Du XZ, Yang H. MicroRNA-27a Inhibits Cell Migration and Invasion of Fibroblast-Like Synoviocytes by Targeting Follistatin-Like Protein 1 in Rheumatoid Arthritis. Mol Cells. 2016 Aug 31;39(8):611-8. doi: 10.14348/molcells.2016.0103. Epub 2016 Aug 8.

  PMID: 27498552 RESULT

• Sun M, You H, Hu X, Luo Y, Zhang Z, Song Y, An J, Lu H. Microglia-Astrocyte Interaction in Neural Development and Neural Pathogenesis. Cells. 2023 Jul 27;12(15):1942. doi: 10.3390/cells12151942.

  PMID: 37566021 RESULT

• Zheleznyakova GY, Piket E, Needhamsen M, Hagemann-Jensen M, Ekman D, Han Y, James T, Khademi M, Al Nimer F, Scicluna P, Huang J, Kockum I, Faridani OR, Olsson T, Piehl F, Jagodic M. Small noncoding RNA profiling across cellular and biofluid compartments and their implications for multiple sclerosis immunopathology. Proc Natl Acad Sci U S A. 2021 Apr 27;118(17):e2011574118. doi: 10.1073/pnas.2011574118.

  PMID: 33879606 RESULT

• Yang J, Hamade M, Wu Q, Wang Q, Axtell R, Giri S, Mao-Draayer Y. Current and Future Biomarkers in Multiple Sclerosis. Int J Mol Sci. 2022 May 24;23(11):5877. doi: 10.3390/ijms23115877.

  PMID: 35682558 RESULT

• Tsuchikawa Y, Kamei N, Sanada Y, Nakamae T, Harada T, Imaizumi K, Akimoto T, Miyaki S, Adachi N. Deficiency of MicroRNA-23-27-24 Clusters Exhibits the Impairment of Myelination in the Central Nervous System. Neural Plast. 2023 Mar 22;2023:8938674. doi: 10.1155/2023/8938674. eCollection 2023.

  PMID: 37006814 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rasha Mohammed, Lecturer

CONTACT

01010024021; rasha.mohamed94@yahoo.com

Omyma Galal, Professor

CONTACT

01006807029; omyma_galal@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of medical physiology

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02