Sympathetic Nerve Response Incited by Biodiesel Exhaust Exposure

NCT ID: NCT03698344

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2019-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Exposure to Pollution

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biodiesel exhaust exposure

A single arm study in which first a filtered air baseline muscle sympathetic nerve activity (MSNA) is recorded with and without an exposure mask. When measurements have been secured exposure to dilute biodiesel exhaust will start.

Group Type EXPERIMENTAL

Biodiesel exhaust exposure

Intervention Type OTHER

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

Interventions

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Biodiesel exhaust exposure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Jenny Bosson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenny A Bosson, MD;PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Umu-2018-348-32M

Identifier Type: -

Identifier Source: org_study_id

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