Exposure to Polluted AirNCT05758129
Association Between PM2.5 Exposure and Ferroptosis in Seizures Patients
An observational study of Exposure to Polluted Air, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Exposure to Polluted Air
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 25 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Recently diagnosed with epilepsy (< 2 months)
- living in this city for more than two years
- no exposure to any chemistry pollution before
Who cannot join
- abnormal IL-6 level before starting this pilot cohort
- other neurological disorders except for epilepsy;
- endocrine diseases;
- cancer
- receive anti-proinflammatory cytokines therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of JiangNan University, Department of Pediatrics
Wuxi, Jiangsu, 226600
About this study
Official title: 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
Read the 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:
- 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;
- Recorded the PM2.5 level in two cities every 5 days between 2022.12 and 2023.3 to compare the difference;
- Interleukin-6 ELISA（IL6） KIT was used to compare the proinflammatory cytokine level in two groups
- 4 Hydroxynonenal （4HNE） ELISA KIT was used to compare the lipid reactive oxygen species level in two groups
- 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
- 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'
- Conditions
- Exposure to Polluted Air
- Keywords
- PM2.5, seizures, IL-6, Nrf2, ferroptosis
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The level changes of baseline IL6 three months later
Biomarkers of proinflammatory cytokine
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Dec 2022
- Primary completion10 Mar 2023 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Polluted AirStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758129
- Sponsor's protocol ID
- 2022/11/16
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between PM2.5 Exposure and Nrf2-depended Ferroptosis Changes in Seizures Patients
- ClinicalTrials.gov ID
- NCT05758129
- Acronym / sponsor ID
- 2022/11/16
- Conditions
- Exposure to Polluted Air
- Keywords
- PM2.5, seizures, IL-6, Nrf2, ferroptosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 10 Mar 2023 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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;
- Recorded the PM2.5 level in two cities every 5 days between 2022.12 and 2023.3 to compare the difference;
- Interleukin-6 ELISA（IL6） KIT was used to compare the proinflammatory cytokine level in two groups
- 4 Hydroxynonenal （4HNE） ELISA KIT was used to compare the lipid reactive oxygen species level in two groups
- 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
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Recently diagnosed with epilepsy (< 2 months)
- living in this city for more than two years
- no exposure to any chemistry pollution before
Key exclusion criteria (5 listed)
- abnormal IL-6 level before starting this pilot cohort
- other neurological disorders except for epilepsy;
- endocrine diseases;
- cancer
- receive anti-proinflammatory cytokines therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Polluted Air, run by Affiliated Hospital of Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.