EPA Human Studies Facility
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT01475968
The purpose of this study is to examine the acute health effects of concentrated ambient ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without lifestyle changes or medical intervention these patients are at considerable risk for developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure pre-, post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population will result in changes in vascular and endothelial response as assessed by flow-mediated dilatation of the brachial artery and various heart rate variability and blood endpoints. This study and similar studies of susceptible populations are needed to provide the EPA with information regarding the health risks associated with ambient levels of UF PM.
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Notify Me25 year–70 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrafine (particle diameter less than 2.5 microns) Air Pollution Particulate Matter, concentrated from the ambient air outside of the Chapel Hill EPA Human Studies Facility
Other names: ultrafine particulate matter, concentrated ambient particulates (CAPS)
Filtered Air
Other names: clean air
Time frame: change from baseline 0 hr after exposure, and change from baseline 20 hr after exposure. There will be at leat 2 weeks between the exposures
Time frame: change from baseline 0 hr after exposure, and change from baseline 20 hr after exposure. There will be at leat 2 weeks between the exposures
10 minute electrocardiogram recording (measure by Holter ECG) in which the subject has been resting for 20 minutes prior. Collected on a Mortara H12+ 12-Lead ECG Recorder (Mortara Instrument, Inc., Milwaukee, WI). The digitally recorded ECGs were sampled at 180 Hz and all data were stored on flash cards before processing.
David Diaz-Sanchez
Fed
Physiological Changes in Adults With Metabolic Syndrome Exposed to Concentrated Ultrafine Chapel Hill Air Particles
Acronym: XCON
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