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The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00745693
First received: September 2, 2008
Last updated: September 4, 2008
Last verified: September 2008

September 2, 2008
September 4, 2008
March 2008
May 2008   (final data collection date for primary outcome measure)
Change in forearm blood flow following infusion of endothelin-1 or the endothelin receptor antagonists BQ-123 & BQ-788 [ Time Frame: 2 hours after exposure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745693 on ClinicalTrials.gov Archive Site
  • 24 hour mean blood pressure (ambulatory monitoring) [ Time Frame: 24 hours following the exposure ] [ Designated as safety issue: No ]
  • Systemic endothelin-1 and big endothelin-1 concentrations [ Time Frame: At baseline, and immediately, 1, 2, 3, 4, 6 and 24 hours after exposure ] [ Designated as safety issue: No ]
  • Changes in arterial stiffness (pulse-wave velocity) [ Time Frame: During and for the 1 hour after the exposure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin
The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin

The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor) in the adverse vascular effects demonstrated after exposure to air pollution

Air pollution is a major problem, and can be linked to around 5% of all deaths worldwide each year. There are strong associations between air pollution exposure and heart disease but we do not yet understand how these harmful effects are mediated. Understanding this mechanism is likely to have a major impact on the way we treat patients with heart disease and have the potential to shape future environmental health policy. The upregulation of Endothelin-1 provides a plausible mechanism for these harmful effects, and we plan to investigate this in more depth in the human forearm following exposure to diesel exhaust.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Coronary Disease
  • Drug: Endothelin-1
    Intra-arterial infusion of Endothelin-1 at 5pmol/min for 1 hour during venous occlusion plethysmography
    Other Names:
    • ET-1
    • American Peptides - 88-1-10 (ET-1)
  • Drug: BQ-123 and BQ-788
    1 hour intra-arterial infusion of BQ-123 at 10nmol/min followed by co-infusion of BQ-788 at 1nmol/min for a further hour during forearm venous occlusion plethysmography
    Other Names:
    • American Peptides - 88-2-10 (BQ-123)
    • American Peptides - 88-2-55 (BQ-788)
  • Experimental: 1
    1 hour exposure to filtered air, followed by forearm venous occlusion plethysmography at 2 hours after the exposure and infusion of endothelin-1 (5pmol/min)
    Intervention: Drug: Endothelin-1
  • Experimental: 2
    1 hour exposure to filtered air, followed by forearm venous occlusion plethysmography at 2 hours after the exposure and infusion of endothelin receptor antagonists BQ-123 and BQ-788
    Intervention: Drug: BQ-123 and BQ-788
  • Experimental: 3
    1 hour exposure to dilute diesel exhaust (300mcg/m3), followed by forearm venous occlusion plethysmography at 2 hours after the exposure and infusion of endothelin-1 (5pmol/min)
    Intervention: Drug: Endothelin-1
  • Experimental: 4
    1 hour exposure to dilute diesel exhaust (300mcg/m3), followed by forearm venous occlusion plethysmography at 2 hours after the exposure and infusion of endothelin receptor antagonists BQ-123 and BQ-788
    Intervention: Drug: BQ-123 and BQ-788

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Use of regular medication
  • Cigarette smoking
  • Significant occupational exposure to air pollution
  • Intercurrent illness
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00745693
Res08/A116
No
Dr Jeremy Langrish, University of Edinburgh
University of Edinburgh
Umeå University
Principal Investigator: Jeremy P Langrish, MB BCh MRCP University of Edinburgh
Study Director: Anders Blomberg, MD Umeå University
Study Director: Thomas Sandström, MD Umeå University
Study Director: David E Newby, MD FRCP University of Edinburgh
University of Edinburgh
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP