SH-SS and GSH-GSSG Homeostasis in Post-stroke Patients

Stroke Clinical Trial

Official title:

Association of Extracellular Thiol-disulfide and Intracellular Oxidized-reduced Glutathione Homeostasis With Severity and Clinical Prognosis of Post-stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884555
• Other study ID #: AIBU-FTR-TA-01
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In patients undergoing physical therapy after stroke, extracellular thiol-disulfide balance and intracellular oxidized-reduced glutathione balance levels will be monitored. The main objectives of this study are; (1) to determine the differences between thiol-disulfide and GSH-GSSG balances in stroke patients compared to healthy volunteers, (2) to evaluate the relationship of these balances with the severity of stroke, (3) to determine the predictive value of the levels of these balances on clinical prognosis and functional recovery outcomes, and (4) to investigate and to examine the effects of the physical therapy process on these parameters and functional recovery and their relationship with each other.

Description:

Stroke is among the most common causes of all deaths and Disability-Adjusted Life Years (DALYs) in the world. There is a close relationship between stroke pathophysiology and post-stroke clinic with oxidative stress. Thiol-disulfide homeostasis systems, which is one of the important extracellular and intracellular oxidative stress markers, showing antioxidant capacity with SH form, and oxidative status with disulfide (SS) form. In this study, we aimed to evaluate the relationship between the clinical outcome of subacute stroke patients and extracellular thiol-disulfide (SH-SS) and intracellular oxidized-reduced glutathione (GSSG-GSH) homeostasis and the comparison of these with healthy volunteers. In addition, the effect of the rehabilitation program on these oxidative stress markers and clinical scores and the predictive value of these oxidative stress parameters on prognosis were also evaluated. The main objectives of this study are; (1) to determine the differences between thiol-disulfide and GSH-GSSG balances in stroke patients compared to healthy volunteers, (2) to evaluate the relationship of these balances with the severity of stroke, (3) to determine the predictive value of the levels of these balances on clinical prognosis and functional recovery outcomes, and (4) to investigate and to examine the effects of the physical therapy process on these parameters and functional recovery and their relationship with each other.

In this study, which is designed as a prospective observational study, patients with subacute stroke who have a stroke for the first time and are admitted to the hospital for the first rehabilitation treatment and healthy volunteers (control group) will be included. The clinical conditions of the patients will be evaluated at the beginning and after the 4-week rehabilitation program at the time of discharge by National Institutes of Health Stroke Scale Scores (NIHSS), modified Rankin Scale (mRS) and Barthel Daily Living Activities Index (BI). Serum and whole blood samples will be obtained from the patient group at the beginning and at discharge, and from the control group. The SH-SS homeostasis parameters (SH, Total SH, SS and SS / SH percent ratio) from serum samples and GSSG-GSH homeostasis parameters (GSH, Total GSH, GSSG and GSSG / GSH percentage ratio) from whole blood samples will be determined. Age, gender, hemiplegic side, type of stroke will be noted. Later, statistical analysis will be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 31, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of a first-ever stroke verified by computed tomography (CT) or magnetic resonance imaging (MRI) reports

• admitted to the hospital for standard neurorehabilitation within 1 to 6 months of stroke onset

• healthy individuals (for control group)

Exclusion Criteria:

• significant acute medical illness (e.g., autoimmune disease, infection, tumor, heart failure, renal or liver dysfunction)

• significant acute neurological illness other than stroke (e.g., head trauma, brain abscess, brain tumor, migraine attack, seizure)

• cannot adapt to work

• previous history of neurorehabilitation therapy

• taking the antioxidant supplements

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Standard neurorehabilitation
Routine post-stroke rehabilitation

Diagnostic Test:
• Thiol-Disulphide Homeostasis
Monitoring the levels of thiol and disulphide in serum
• Oxidized-reduced Glutathione Homeostasis
Monitoring the levels of intracellular oxidized glutathione and reduced glutathione in whole blood samples

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Alisik, M., Neselioglu, S., & Erel, O. (2019). A colorimetric method to measure oxidized, reduced and total glutathione levels in erythrocytes, Journal of Laboratory Medicine, 43(5), 269-277

Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. Review. — View Citation

Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. — View Citation

Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7. — View Citation

Küçükdeveci AA, Yavuzer G, Tennant A, Süldür N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIHSS Scores	National Institutes Of Health Stroke Scale Scores	at baseline (pre-treatment)
Primary	NIHSS Scores	National Institutes Of Health Stroke Scale Scores	after 4 weeks of treatment (post-treatment)
Primary	mRS	modified Rankin Scales	at baseline (pre-treatment)
Primary	mRS	modified Rankin Scales	after 4 weeks of treatment (post-treatment)
Primary	BI	Barthel Index for Activities of Daily Living	at baseline (pre-treatment)
Primary	BI	Barthel Index for Activities of Daily Living	after 4 weeks of treatment (post-treatment)