Sympathetic Nerve Response Incited by Biodiesel Exhaust Exposure

September 27, 2019 updated by: Jenny Bosson, Umeå University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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

  • Sweden
      • Umeå, Sweden
        • Dept of Medicine, Lung and Allergy section, University Hospital

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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microneurography
Time Frame: 1 hour
Microneurography recording of muscle sympathetic nervous system activity
1 hour

Collaborators and Investigators

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

Sponsor

Umeå University

Investigators

  • Principal Investigator: Jenny A Bosson, MD;PhD, Umeå 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)

October 29, 2018

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Umu-2018-348-32M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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