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Diesel Exhaust Inhalation, Systemic Nitric Oxide Inhibition and Cardiac Output

NCT ID: NCT01060930

Last Updated: 2011-12-16

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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Exposure to combustion-derived fine particulate air pollution is associated with cardiovascular mortality and morbidity. In previous studies, exposure to diesel exhaust (a major constituent of urban particulate air pollution) has been shown to impair two important functions of the vascular endothelium: vascular vasomotor function and endogenous fibrinolysis. Our subsequent studies suggest this impairment of vascular function is mediated by a reduction in nitric oxide bioavailability. In this study we aim to investigate the cardiovascular responses to systemic nitric oxide synthase inhibition following exposure to dilute diesel exhaust.

Detailed Description

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Conditions

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Vascular Function in Healthy Volunteers

Keywords

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Nitric oxide Diesel exhaust Air pollution Cardiac output Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diesel exhaust exposure

1 hour exposure to dilute diesel exhaust \~ 300 mcg/m3 - during intermittent exercise

Group Type EXPERIMENTAL

Intravenous infusion of L-NMMA and Nor-epinephrine

Intervention Type DRUG

Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min. Each infusion to run over 15 mins and separated by 45 min to allow return to baseline. Drugs infused in a randomised order. During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.

Air exposure

1 hour exposure to filtered air during intermittent exercise

Group Type EXPERIMENTAL

Intravenous infusion of L-NMMA and Nor-epinephrine

Intervention Type DRUG

Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min. Each infusion to run over 15 mins and separated by 45 min to allow return to baseline. Drugs infused in a randomised order. During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.

Interventions

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Intravenous infusion of L-NMMA and Nor-epinephrine

Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min. Each infusion to run over 15 mins and separated by 45 min to allow return to baseline. Drugs infused in a randomised order. During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.

Intervention Type DRUG

Other Intervention Names

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L-NMMA: Clinalfa Basic, Bachem, Germany

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Non smokers
* No regular medication (except oral contraceptive)
* No recent respiratory tract infection (within 6 weeks)

Exclusion Criteria

* History of asthma or respiratory disease
* Smoking history
* Pregnancy (positive urinary pregnancy test)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy P Langrish, MB BCh MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University Hospital Umeå

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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Langrish JP, Unosson J, Bosson J, Barath S, Muala A, Blackwell S, Soderberg S, Pourazar J, Megson IL, Treweeke A, Sandstrom T, Newby DE, Blomberg A, Mills NL. Altered nitric oxide bioavailability contributes to diesel exhaust inhalation-induced cardiovascular dysfunction in man. J Am Heart Assoc. 2013 Feb 19;2(1):e004309. doi: 10.1161/JAHA.112.004309.

Reference Type DERIVED
PMID: 23525434 (View on PubMed)

Other Identifiers

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DISCO

Identifier Type: -

Identifier Source: org_study_id