Biodiesel Exhaust, Acute Vascular and Endothelial Responses

Healthy Clinical Trial

— BEAVER  

Official title:

Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337882
• Other study ID #: BEAVER
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: November 30, 2011
• Start date: April 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. The last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within European markets. In 2007 researchers at the EPA released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. They suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. In this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 20 healthy, non-smoking subjects, age 20-55 year old, both genders.

All subjects undergo a general health examination and are required to have:

Normal clinical examination Normal EKG Normal routine blood tests Normal lung function

Exclusion Criteria:

• Cardiovascular disease

• Diabetes Mellitus

• Asthma and/or allergy

• Respiratory infection within 3 weeks of the study

• Antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)

• Female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Forearm venous occlusion plethysmography study
Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelium-dependent (bradykinin [100, 300 & 1000 pmol/min]; acetylcholine [5, 10 & 20 µg/min]) and -independent [sodium nitroprusside [2, 4 & 8 µg/min]; verapamil [10, 30 & 100 µg/min]) vasodilators. Each drug to be infused for 6 mins at each dose in increasing concentrations. 0.9% sodium chloride will be infused for 20 min between each individual drug to allow washout.

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular vasomotor and fibrinolytic function	Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent (bradykinin and acetylcholine) and -independent (sodium nitroprusside and verapamil) vasodilators. Fibrinolytic function assessed by blood sampling after infusion of bradykinin for tissue plasminogen activator and plasminogen activator inhibitor-1.	4-6 hours after exposure	No
Secondary	Respiratory function tests	Basic spirometry will be performed at baseline and 6 hours after each exposure	6 hours after exposure	No
Secondary	Inflammatory markers	Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators	Baseline and up to 24 hours after exposure	No
Secondary	Central arterial stiffness	Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure	Baseline and post exposure	No