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Health Effects of Biodiesel Exhaust Exposure (BD100)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883466
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
Umeå University

Brief Summary:
Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.

Condition or disease Intervention/treatment Phase
Vascular Endothelium Other: Forearm venous occlusion plethysmography study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cardiovascular Effects of Exposure to 100% Biodiesel Exhaust in Man
Study Start Date : September 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: Diesel exhaust exposure
1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise
Other: Forearm venous occlusion plethysmography study
Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.

Experimental: Biodiesel exhaust exposure
1 hour exposure to dilute biodiesel exhaust (generated at same running conditions as diesel exhaust) during intermittent exercise
Other: Forearm venous occlusion plethysmography study
Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.




Primary Outcome Measures :
  1. Vascular vasomotor and fibrinolytic function [ Time Frame: 4-6 hours after exposure ]
    Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators (bradykinin & acetylcholine and sodium nitroprusside & verapamil respectively). Tissue plasminogen activator and plasminogen activator inhibitor-1 were analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function. These composite outcome measures will together indicate vascular vasomotor function.


Secondary Outcome Measures :
  1. Respiratory function tests [ Time Frame: Baseline, 6 and 24 hours after exposure ]
    Basic spirometry and fraction of exhaled nitric oxide (FeNO) are performed at baseline, as well as 6 and 24 hours after exposure.

  2. Effects of exposure on metabolomic markers in plasma [ Time Frame: Baseline and 2, 4 & 24 hours after exposure ]
    Blood samples taken at baseline as well as at 2, 4 and 24 hours post-exposure will be stored as plasma for metabolomic analysis. Since inflammatory mediators such as eicosanoids and other fatty acid metabolites have been seen as likely key players in air pollution response, particular interest will be directed towards the oxylipin metabolome, which will be analyzed according to established protocols. These samples are taken in EDTA tubes and placed on ice. They are centrifuged at a low temperature and then divided into 1ml allotments. These are then stored in a freezer until analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.

Exclusion Criteria:

  • Diabetes Mellitus
  • Cardiovascular disease
  • Asthma
  • Respiratory infection within 2 weeks of the study
  • Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
  • Smokers or regular snus usage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883466


Locations
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Sweden
Umeå University Hospital
Umeå, Sweden, 90185
Sponsors and Collaborators
Umeå University
University of Edinburgh
Investigators
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Principal Investigator: Jenny A Bosson, MD, PhD Umeå University
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT01883466    
Other Study ID Numbers: UMU-12-14031
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Umeå University:
Air Pollution
Biodiesel exhaust
Diesel exhaust
Vascular function
Fibrinolysis
Acute endothelial responses