NCT02892279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

September 2, 2016

Last Update Submit

February 5, 2018

Conditions

Healthy

Keywords

MicroneurographyAir pollution

Outcome Measures

Primary Outcomes (1)

  • Microneurography

    Microneurography recording of muscle sympathetic nervous system activity

    1 hour

Study Arms (1)

Diesel exhaust exposure

EXPERIMENTAL

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

Interventions

Diesel exhaust exposureOTHER

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

Diesel exhaust exposure

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, Sweden

Location

Related Publications (1)

  • Rankin GD, Kabele M, Brown R, Macefield VG, Sandstrom T, Bosson JA. Acute Exposure to Diesel Exhaust Increases Muscle Sympathetic Nerve Activity in Humans. J Am Heart Assoc. 2021 May 18;10(10):e018448. doi: 10.1161/JAHA.120.018448. Epub 2021 May 4.

    PMID: 33942621DERIVED

Study Officials

  • Jenny Bosson, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

SE(1)