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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698344
Other study ID # Umu-2018-348-32M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date February 15, 2019

Study information

Verified date September 2019
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The adverse effects of current ambient air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. Similar cardiovascular responses seen post diesel exposure have been shown to occur following biodiesel exhaust exposure as well. In the current project the investigators aim to determine whether an acute exposure to biodiesel exhaust (rapeseed methyl ester) causes impacts on sympathetic nervous system activation in healthy volunteers.


Description:

Brief as well as chronic exposures to ambient air pollution have been linked with increases in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations between air pollution exposure and adverse cardiovascular effects are found for combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is found in diesel engine emissions as well as biodiesel exhaust (RME, rapeseed methyl ester). Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine and ultrafine particulate air pollution alters vascular function has yet to be determined. Microneurography is a method that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic nervous activity. The current study will employed microneurography techniques to evaluate autonomic function in association with inhaled biodiesel exhaust exposure in healthy human volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 15, 2019
Est. primary completion date December 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Criteria:

Inclusion Criteria:

Healthy (normal ECG, lung function, blood sample, clinical examination)

Exclusion Criteria:

Metabolic disease Cardiovascular disease Respiratory disease BMI = 30 Use of psychoactive medication Infection within 2 weeks of the study Smokers or regular snus usage

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biodiesel exhaust exposure
Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute biodiesel exhaust via mask.

Locations

Country Name City State
Sweden Dept of Medicine, Lung and Allergy section, University Hospital Umeå

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microneurography Microneurography recording of muscle sympathetic nervous system activity 1 hour
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