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| ID | Type | Description | Link |
|---|---|---|---|
| 04-1677 | Other Identifier | UNC IRB |
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| Name | Class |
|---|---|
| Environmental Protection Agency (EPA) | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrafine Air Pollution Particulate Matter | Active Comparator | <2.5 microns concentrated from outside ambient air |
|
| Filtered Air | Sham Comparator | Filtered Air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrafine Air Pollution Particulate Matter | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Vascular Function |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in heart rate variability | 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. | 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 |
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Inclusion Criteria:
Age between 25-70 years old
Metabolic syndrome as defined by the participant having at least three of the following criteria:
Normal resting electrocardiograph (ECG).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Devlin, PhD | US EPA | Principal Investigator |
| Candice B Smith, PhD | US EPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPA Human Studies Facility | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D052638 | Particulate Matter |
| D004780 | Environment, Controlled |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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|
| Filtered Air | Other | Filtered Air |
|
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| D009750 |
| Nutritional and Metabolic Diseases |