Association Between PM2.5 Exposure and Ferroptosis in Seizures Patients

March 5, 2023 updated by: Affiliated Hospital of Jiangnan University

Association Between PM2.5 Exposure and Nrf2-depended Ferroptosis Changes in Seizures Patients

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background: Despite the exact mechanism of the effects of air pollution (PM2.5) on the central nervous system is still under debate. There is increasing evidence that air pollution (PM2.5) will affect neurodegenerative diseases including epilepsy. It is well known that air pollution (PM2.5) will increase the level of proinflammatory cytokine released by microglia, and advanced research indicated the level of interleukin-6 will affect epilepsy symptoms. In addition, our previous research indicated that Nrf2 plays a crucial role in seizure symptoms and cognitive function (NCT05269901). However, whether PM2.5-induced proinflammatory cytokine released by microglia will change Nrf2- dependent ferroptosis to facilitate seizure symptoms and cognitive function is still unexplored. Therefore, this pilot cohort study aims to discover the potential association between PM2.5 exposures and the changes in the interleukin-6 level and Nrf2- dependent ferroptosis pathway

Methods:

  1. The investigators first enrolled 30 low PM2.5 exposure epileptic children and aged-matched high PM2.5 exposure children who were recently diagnosed with epilepsy (< 2 months)from two cities (Yangzhou and Xuzhou) as the control and air pollution group based on previous PM2.5 records;
  2. Recorded the PM2.5 level in two cities every 5 days between 2022.12 and 2023.3 to compare the difference;
  3. Interleukin-6 ELISA（IL6） KIT was used to compare the proinflammatory cytokine level in two groups
  4. 4 Hydroxynonenal （4HNE） ELISA KIT was used to compare the lipid reactive oxygen species level in two groups
  5. Real-Time Quantitative PCR（RT-qPCR） was used to compare messenger RNA (mRNA) expression of the Nrf2-dependent ferroptosis pathway (Nrf2, SLC7A11, GPX4) Detailed Methods protocol

1. PM2.5 level source: the PM2.5 levels were recorded via the data from the Ministry of Ecology and Environment of the People's Republic of China (air.cnemc.cn:18007/) 2. Sample collection: At the end of this study, the enrolled participant will come to the hospital to collect peripheral Blood (Affiliated Hospital of Jiangnan University and Xuzhou Children's Hospital, respectively), and the blood samples were collected into ethylene diamine tetraacetic acid（EDTA） vacutainer tubes and then divided into leukocytes and plasma for further experiments 3. Interleukin-6 and 4HNE: Plasma IL-6 and 4HNE concentrations were detected by the competitive ELISA method 4. RTqPCR sequence: h-GPX4 forward: 5'-GAGGCAAGACCGAAGTAAACTAC-3' h-GPX4 reverse: 5'-CCGAACTGGTTACACGGGAA-3' h-SLC7A11 forward: 5'-TCTCCAAAGGAGGTTACCTGC-3' h-SLC7A11 reverse: 5'-AGACTCCCCTCAGTAAAGTGAC-3' h-Nrf2 forward5'-ATAGCTGAGCCCAGTATC-3' h-Nrf2 reverse 5'- CATGCACGTGAGTGCTCT-3' h-GAPDH forward: 5'-GGAGCGAGATCCCTCCAAAAT-3' h-GAPDH reverse: 5'-GGCTGTTGTCATACTTCTCATGG-3'

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 226600
        • Affiliated Hospital of JiangNan University, Department of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. abnormal IL-6 level before starting this pilot cohort
  2. other neurological disorders except for epilepsy;
  3. endocrine diseases;
  4. cancer
  5. receive anti-proinflammatory cytokines therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The level changes of baseline IL6 three months later
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital of Jiangnan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/11/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exposure to Polluted Air

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings