- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01337882
Biodiesel Exhaust, Acute Vascular and Endothelial Responses (BEAVER)
November 30, 2011 updated by: Jeremy Langrish, University of Edinburgh
Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
-
Umeå, Sweden, 901 85
- Umeå University Hospital
-
-
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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 (approximate PM10 concentration 300 mcg/m3) during intermittent exercise
|
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.
|
Experimental: Biodiesel exhaust exposure
1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory function tests
Time Frame: 6 hours after exposure
|
Basic spirometry will be performed at baseline and 6 hours after each exposure
|
6 hours after exposure
|
Inflammatory markers
Time Frame: Baseline and up to 24 hours after exposure
|
Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators
|
Baseline and up to 24 hours after exposure
|
Central arterial stiffness
Time Frame: Baseline and post exposure
|
Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure
|
Baseline and post exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jenny A Bosson Damewood, MD PhD, Umea University
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
April 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
April 18, 2011
First Posted (Estimate)
April 19, 2011
Study Record Updates
Last Update Posted (Estimate)
December 1, 2011
Last Update Submitted That Met QC Criteria
November 30, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEAVER
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Forearm venous occlusion plethysmography study
-
University of CambridgeCompletedCardiovascular DiseaseUnited Kingdom
-
Umeå UniversityUniversity of EdinburghCompleted
-
University of EdinburghUmeå UniversityCompleted
-
Cambridge University Hospitals NHS Foundation TrustWellcome Trust; University of CambridgeCompletedPulmonary Hypertension | COPDUnited Kingdom
-
Chinese University of Hong KongSugardown Company LimitedCompletedPre-DiabetesHong Kong
-
University of EdinburghNHS LothianSuspendedHeart Disease | Vascular DiseaseUnited Kingdom
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedPostural Tachycardia Syndrome (POTS)United States
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of AarhusDanish Cancer SocietyCompletedCardiovascular Disease | Breast Neoplasms | Metabolic Syndrome | Endothelial DysfunctionDenmark
-
Imperial College LondonTerminated