- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060930
Diesel Exhaust Inhalation, Systemic Nitric Oxide Inhibition and Cardiac Output (DISCO)
December 15, 2011 updated by: University of Edinburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
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Umeå, Sweden
- University Hospital Umeå
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diesel exhaust exposure
1 hour exposure to dilute diesel exhaust ~ 300 mcg/m3 - during intermittent exercise
|
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.
Other Names:
|
Experimental: Air exposure
1 hour exposure to filtered air during intermittent exercise
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure response to NO inhibition
Time Frame: Blood pressure will be measured continuously through the vascular study using intra-arterial monitoring
|
Blood pressure will be measured continuously through the vascular study using intra-arterial monitoring
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate response to systemic nitric oxide inhibition
Time Frame: Heart rate will be measured continuously throughout the study period using continous electrocardiography
|
Heart rate will be measured continuously throughout the study period using continous electrocardiography
|
Central arterial stiffness following NO inhibition
Time Frame: Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Cardiac output during NO inhibition
Time Frame: Measured at baseline, and every 5 minutes during the 2-hour vascular study
|
Measured at baseline, and every 5 minutes during the 2-hour vascular study
|
Plasma nitrite (NO) concentrations
Time Frame: Measured at baseline, and every 15 minutes during the 2-hour vascular study
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Measured at baseline, and every 15 minutes during the 2-hour vascular study
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Platelet activation and platelet-monocyte binding
Time Frame: Measured at baseline, and every 30 minutes during the 2-hour vascular study
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Measured at baseline, and every 30 minutes during the 2-hour vascular study
|
Heart rate variability
Time Frame: Heart rate will be measured continuously throughout the study period using continous electrocardiography, and HRV subsequently determined for the whole study period and the 2-hour vascular study separately
|
Heart rate will be measured continuously throughout the study period using continous electrocardiography, and HRV subsequently determined for the whole study period and the 2-hour vascular study separately
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeremy P Langrish, MB BCh MRCP, University of Edinburgh
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.
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
March 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 28, 2010
First Submitted That Met QC Criteria
February 1, 2010
First Posted (Estimate)
February 2, 2010
Study Record Updates
Last Update Posted (Estimate)
December 16, 2011
Last Update Submitted That Met QC Criteria
December 15, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Aspiration
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Norepinephrine
- Epinephrine
- omega-N-Methylarginine
Other Study ID Numbers
- DISCO
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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