Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure

February 5, 2018 updated by: Jenny Bosson, Umeå University
The adverse effects of air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. In the current project the investigators aim to determine whether an acute exposure to diesel exhaust 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 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. Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine 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 air pollution exposure in healthy human volunteers.

Study Type

Interventional

Enrollment (Actual)

15

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

No

Genders Eligible for Study

Male

Description

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: Diesel exhaust exposure
A single arm study in which first a baseline muscle sympathetic nerve activity (MSNA) is recorded with and without an exposure mask. When measurements have been secured exposure to dilute diesel exhaust will start.
Other: Diesel exhaust exposure
Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute diesel 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 Bosson, MD, PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Umu-2016-57-31

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

product manufactured in and exported from the U.S.

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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