Association Between PM2.5 Exposure and Ferroptosis in Seizures Patients

NCT05758129 | Unknown

• 1 other identifier: 2022/11/16
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This cohort study aims to discover the possible effects of PM2.5 exposures on the Nrf2- dependent ferroptosis pathway in seizure patients. This observational cohort's main question is whether PM2.5 exposures will affect the Nrf2- dependent ferroptosis pathway in seizure patients. Participants will be divided into two groups: the control group and the air pollution to detect the biomarkers of the Nrf2- dependent ferroptosis pathway in seizure patients

Conditions

Exposure to Polluted Air

Keywords

PM2.5; seizures; IL-6; Nrf2; ferroptosis

Outcome Measures

Primary Outcomes (3)

• The level changes of baseline IL6 three months later

  Biomarkers of proinflammatory cytokine

  From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 90 days

• The level changes of baseline 4HNE three months later

  Biomarkers of ferroptosis, an indicator of lipid reactive oxygen species

  From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 90 days

• The level changes of baseline of mRNA expression of the Nrf2-dependent ferroptosis three months later

  Biomarkers of the Nrf2- dependent ferroptosis

  From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 90 days

Study Arms (2)

The control group

the invited recently diagnosed with epilepsy (\< 2 months) live in Wuxi, Jiangsu, China (low PM2.5 level based on previous official PM2.5 records)

The PM2.5 exposure group

the invited recently diagnosed with epilepsy live in Xuzhou, Jiangsu, China (high PM2.5 level based on previous official PM2.5 records)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The control group will be selected from the invited epileptic children who live in Wuxi city via the website, email, and poster. The PM2.5 group will be selected from the invited volunteers who live in Xuzhou city via the website, email, and poster.

You may qualify if:

• Recently diagnosed with epilepsy (\< 2 months)
• living in this city for more than two years
• no exposure to any chemistry pollution before

You may not qualify if:

• abnormal IL-6 level before starting this pilot cohort
• other neurological disorders except for epilepsy;
• endocrine diseases;
• cancer
• receive anti-proinflammatory cytokines therapy

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of JiangNan University, Department of Pediatrics

Wuxi, Jiangsu, 226600, China

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 7, 2023
• Study Start: December 1, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 25, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-02

Locations

CN (1)