Grantee Research Project Results
Publications Details for Grant Number R834797C002
Cardiometabolic, Autonomic, and Airway Toxicity of Acute Exposures to PM2.5 from Multipollutant Atmospheres in the Great Lakes Region
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Reference Type | Citation | Progress Report Year | Document Sources |
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Abstract | Allen KM, Brooks P, Dereski M, Lewandowski R, Hotchkiss I, Jackson-Humbles D, Brandenberger C, Bramble L, Wagner JG, Harkema J. Inhaled ozone induces metabolic abnormalities in mice fed a high-fructose diet. The Toxicologist 2013;132(1):12. |
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Abstract | Allen K, Lewandowski R, Wagner JG, Harkema JR. Inhalation exposures to ozone induce insulin resistance and pulmonary pathology in Type II diabetes-prone mice. The Toxicologist 2014;138(1):623. |
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Abstract | Baker GL, McKinney WJ, Phalen RF, Oldham M, Harkema JR, Higuchi MA. Inhalation studies: challenges and complexities. The Toxicologist 2014;138(1):1. |
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Abstract | Ong C, Allen K, Brandenberger C, Jackson-Humbles D, Bramble L, Lewandowski R, Wagner JG, Harkema JR. Development of eosinophilic rhinitis and nasal tissue remodeling in mice episodically exposed to ozone. The Toxicologist 2014;138(1):624. |
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Abstract | Wagner JG, Yang H, Allen KM, Morishita M, Nan B, Mukherjee B, Fink GD, Harkema JR. Suppressed responses in heart rate variability during inhalation exposure to ozone and ambient fine particles in rats on a high-fructose diet. The Toxicologist 2013;132(1):12. |
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Abstract | Wagner JG, Allen K, Nan B, Lewandowski R, Fink G, Harkema JR. Role of transient receptor potential (TRP) channels in ozone-induced decreases in blood pressure and heart rate in rats on a high fructose diet. American Journal of Respiratory and Critical Care 2013;187:A5093. |
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Abstract | Wagner JG. Cardiometabolic interactions of diet and air pollution: field studies with multipollutant atmospheres. The Toxicologist 2014;138(1):545. |
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Abstract | Wagner JG, Kamal AS, Morishita M, Dvonch JT, Harkema JR, Rohr AC. PM2.5-induced tachycardia and hypertension in rats are linked to elemental carbon and specific temperature-resolved carbon subfractions. The Toxicologist 2014;138(1):328-329. |
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Abstract | Wagner JG, Das R, Allen K, Morishita M, Nan B, Mukherjee B, Harkema JR. Cardiovascular depression during inhalation exposure to a mixture of ozone and rural ambient fine particles (PM2.5) in rats on a high fructose diet. American Journal of Respiratory and Critical Care Medicine 2014;189:A1668. |
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Journal Article | Balasubramanian P, Sirivelu MP, Weiss KA, Wagner JG, Harkema JR, Morishita M, Mohankumar PS, Mohankumar SM. Differential effects of inhalation exposure to PM 2.5 on hypothalamic monoamines and corticotrophin releasing hormone in lean and obese rats. NeuroToxicology 2013;36:106-111. |
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Journal Article | Brandenberger C, Li N, Jackson-Humbles DN, Rockwell CE, Wagner JG, Harkema JR. Enhanced allergic airway disease in old mice is associated with a Th17 response. Clinical & Experimental Allergy 2014;44(10):1282-1292. |
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Journal Article | Brook RD, Bard RL, Kaplan MJ, Yalavarthi S, Morishita M, Dvonch JT, Wang L, Yang H-Y, Spino C, Mukherjee B, Oral EA, Sun Q, Brook JR, Harkema J, Rajagopalan S. The effect of acute exposure to coarse particulate matter air pollution in a rural location on circulating endothelial progenitor cells: results from a randomized controlled study. Inhalation Toxicology 2013;25(10):587-592. |
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Journal Article | Brook RD, Xu X, Bard RL, Dvonch JT, Morishita M, Kaciroti N, Sun Q, Harkema J, Rajagopalan S. Reduced metabolic insulin sensitivity following sub-acute exposures to low levels of ambient fine particulate matter air pollution. The Science of the Total Environment 2013;448:66-71. |
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Journal Article | Brook RD, Bard RL, Morishita M, Dvonch JT, Wang L, Yang HY, Spino C, Mukherjee B, Kaplan MJ, Yalavarthi S, Oral EA, Ajluni N, Sun Q, Brook JR, Harkema J, Rajagopalan S. Hemodynamic, autonomic, and vascular effects of exposure to coarse particulate matter air pollution from a rural location. Environmental Health Perspectives 2014;122(6):624-630. |
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Journal Article | Byrd JB, Morishita M, Bard RL, Das R, Wang L, Sun Z, Spino C, Harkema J, Dvonch JT, Rajagopalan S, Brook RD. Acute increase in blood pressure during inhalation of coarse particulate matter air pollution from an urban location. Journal of the American Society of Hypertension 2016;10(2):133-139. |
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Journal Article | Liu C, Ying Z, Harkema J, Sun Q, Rajagopalan S. Epidemiological and experimental links between air pollution and type 2 diabetes. Toxicologic Pathology 2013;41(2):361-373. |
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Journal Article | Liu C, Xu X, Bai Y, Wang TY, Rao X, Wang A, Sun L, Ying Z, Gushchina L, Maiseyeu A, Morishita M, Sun Q, Harkema JR, Rajagopalan S. Air pollution-mediated susceptibility to inflammation and insulin resistance:influence of CCR2 pathways in mice. Environmental Health Perspectives 2014;122(1):17-26. |
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Journal Article | Liu C, Bai Y, Xu X, Sun L, Wang A, Wang TY, Maurya SK, Periasamy M, Morishita M, Harkema J, Ying Z, Sun Q, Rajagopalan S. Exaggerated effects of particulate matter air pollution in genetic type II diabetes mellitus. Particle and Fibre Toxicology 2014;11:27. |
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Journal Article | Maiseyeu A, Yang H-Y, Ramanathan G, Yin F, Bard RL, Morishita M, Dvonch JT, Wang L, Spino C, Mukherjee B, Badgeley MA, Barajas-Espinosa A, Sun Q, Harkema J, Rajagopalan S, Araujo JA, Brook RD. No effect of acute exposure to coarse particulate matter air pollution in a rural location on high-density lipoprotein function. Inhalation Toxicology 2014;26(1):23-29. |
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Journal Article | Morishita M, Bard RL, Kaciroti N, Fitzner CA, Dvonch T, Harkema JR, Rajagopalan S, Brook RD. Exploration of the composition and sources of urban fine particulate matter associated with same-day cardiovascular health effects in Dearborn, Michigan. Journal of Exposure Science & Environmental Epidemiology 2015;25(2):145-152. |
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Journal Article | Morishita M, Bard RL, Wang L, Das R, Dvonch JT, Spino C, Mukherjee B, Sun Q, Harkema JR, Rajagopalan S, Brook RD. The characteristics of coarse particulate matter air pollution associated with alterations in blood pressure and heart rate during controlled exposures. Journal of Exposure Science & Environmental Epidemiology 2015;25(2):153-159. |
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Journal Article | Ong CB, Kumagai K, Brooks PT, Brandenberger C, Lewandowski RP, Jackson-HumblesDN, Nault R, Zacharewski TR, Wagner JG, Harkema JR. (2016) Ozone-Induced Type 2 Immunity in Nasal Airways: Development and Lymphoid Cell Dependence in Mice. American Journal of Respiratory Cell and Molecular Biology 2016;54(3):331-340. |
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Journal Article | Ong CB, Kumagai K, Brooks PT, Brandenberger C, Lewandowski RP, Jackson-Humbles DN, Nault R, Zacharewski TR, Wagner JG, Harkema JR. Ozone-induced type 2 immunity in nasal airways. Development and lymphoid cell dependence in mice. American Journal of Respiratory Cell and Molecular Biology 2016;54(3):331-340. |
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Journal Article | Pancras JP, Landis MS, Norris GA, Vedantham R, Dvonch JT. Source apportionment of ambient fine particulate matter in Dearborn, Michigan, using hourly resolved PM chemical composition data. The Science of the Total Environment 2013;448:2-13. |
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Journal Article | Rao X, Zhong J, Maiseyeu A, Gopalakrishnan B, Villamena FA, Chen LC, Harkema JR, Sun Q, Rajagopalan S. CD36-dependent 7-ketocholesterol accumulation in macrophages mediates progression of atherosclerosis in response to chronic air pollution exposure. Circulation Research 2014;115(9):770-780. |
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Journal Article | Sun L, Liu C, Xu X, Ying Z, Maiseyeu A, Wang A, Allen K, Lewandowski RP, Bramble LA, Morishita M, Wagner JG, Dvonch JT, Sun Z, Yan X, Brook RD, Rajagopalan S, Harkema JR, Sun Q, Fan Z. Ambient fine particulate matter and ozone exposures induce inflammation in epicardial and perirenal adipose tissues in rats fed a high fructose diet. Particle and Fibre Toxicology 2013;10:43. |
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Journal Article | Vital M, Harkema JR, Rizzo M, Tiedje J, Brandenberger C. Alterations of the murine gut microbiome with age and allergic airway disease. Journal of Immunology Research 2015;2015:892568 (8 pp.). |
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Journal Article | Wagner JG, Allen K, Yang HY, Nan B, Morishita M, Mukherjee B, Dvonch JT, Spino C, Fink GD, Rajagopalan S, Sun Q, Brook RD, Harkema JR. Cardiovascular depression in rats exposed to inhaled particulate matter and ozone: effects of diet-induced metabolic syndrome. Environmental Health Perspectives 2014;122(1):27-33. |
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Journal Article | Wagner JG, Kamal AS, Morishita M, Dvonch JT, Harkema JR, Rohr AC. PM2.5-induced cardiovascular dysregulation in rats is associated with elemental carbon and temperature-resolved carbon subfractions. Particle and Fibre Toxicology 2014;11:25 (10 pp.). |
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Journal Article | Wellenius GA, Boyle LD, Wilker EH, Sorond FA, Coull BA, Koutrakis P, Mittleman MA, Lipsitz LA. Ambient fine particulate matter alters cerebral hemodynamics in the elderly. Stroke 2013;44(6):1532-1536. |
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Journal Article | Xu X, Liu C, Xu Z, Tzan K, Zhong M, Wang A, Lippmann M, Chen LC, Rajagopalan S, Sun Q. Long-term exposure to ambient fine particulate pollution induces insulin resistance and mitochondrial alteration in adipose tissue. Toxicological Sciences 2011;124(1):88-98. |
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Journal Article | Ying Z, Xu X, Bai Y, Zhong J, Chen M, Liang Y, Zhao J, Liu D, Morishita M, Sun Q, Spino C, Brook RD, Harkema JR, Rajagopalan S. Long-term exposure to concentrated ambient PM2.5 increases mouse blood pressure through abnormal activation of sympathetic nervous system:a role for hypothalamic inflammation. Environmental Health Perspectives 2014;122(1):79-86. |
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Journal Article | Kumagai K, Lewandowski R, Jackson-Humbles DN, Li N, Van Dyken SJ, Wagner JG, Harkema JR (2016). Ozone-Induced Nasal Type 2 Immunity in Mice Is Dependent on Innate Lymphoid Cells. American Journal of Respiratory Cell and Molecular Biology 2016;54(6):782-791. |
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Journal Article | Ying Z, Allen K, Zhong J, Chen M, Williams KM, Wagner JG, Lewandowski R, Sun Q, Rajagopalan S, Harkema JR. Subacute inhalation exposure to ozone induces systemic inflammation but not insulin resistance in a diabetic mouse model. Inhalation Toxicology 2016;28(4):155-163. |
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Journal Article | Harkema JR, Hotchkiss LA, Vetter NA, Jackson-Humbles DN, Lewandowski RP, Wagner JG. Strain Differences in a Murine Model of Air Pollutant-induced Nonatopic Asthma and Rhinitis. Toxicologic Pathology 2017;45(1):161-171. |
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Journal Article | Carll, A.P., Crespo, S.M., Filho, M.S., Zati, D.H., Coull, B.A., Diaz, E.A., Raimundo, R.D., Jaeger, T.N.G., Ricci-Vitor, A.L., Papapostolou, V., Lawrence, J.E., Garner, D.M., Perry, B.S., Harkema, J.R., and Godleski, J.J. (2017). Inhaled Ambient-level Traffic-derived Particulates Decrease Cardiac Vagal Influence and Baroreflexes and Increase Arrhythmia in a Rat Model of Metabolic Syndrome. Particle and Fibre Toxicology 14, 16. |
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Journal Article | Zhong J, Allen K, Rao X, Ying Z, Braunstein Z, Kankanala SR, Xia C, Wang X, Bramble LA, Wagner JG, Lewandowski R, Sun Q, Harkema JR, Rajagopalan S (2016). Repeated ozone exposure exacerbates insulin resistance and activates innate immune response in genetically susceptible mice. Inhal Toxicol. 28(9):383-92. PubMed PMID:27240593. |
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Presentation | Allen K, Kopec AK, Zacharewski TR, Wagner JG, Morishita M, Dvonch JT, Harkema JR. Metabolic changes from high-fructose feeding are altered by air pollutant exposure. Presented at the Society of Toxicology 51st Annual Meeting and ToxExpo, San Francisco, CA, March 11-15, 2012. |
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Presentation | Allen K, Lewandowski R, Wagner JG, Harkema JR. Inhalation exposures to ozone induce insulin resistance and pulmonary pathology in type II diabetes-prone mice. Presented at the Society of Toxicology 53rd Annual Meeting and ToxExpo, Phoenix, AZ, March 23-27, 2014 (invited, abstract 2324). |
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Presentation | Baker GL, McKinney WJ, Phalen RF, Oldham M, Harkema JR, Higuchi MA. Inhalation studies: challenges and complexities. Presented at the Society of Toxicology 53rd Annual Meeting and ToxExpo, Phoenix, AZ, March 23-27, 2014 (invited, abstract 5). |
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Presentation | Harkema JR, Kumagai K, Lewandowski R, Jackson-Humbles DN, Li N, and Wagner JG. Innate Lymphoid Cells Mediate Type-2 Immunity in the Lungs of Ozone-Exposed Mice. American Thoracic Society International Conference, San Francisco, CA, May 16, 2016. |
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Presentation | Harkema JR, Jackson-Humbles DN, Lewandowski RP, Wagner JG, and Tighe RM. Rapid Onset of Ozone-Induced Pulmonary Fibrosis in Diabetic KKAy Mice. American Thoracic Society International Conference, San Francisco, CA, May 15, 2016. |
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Presentation | Harkema JR. GLACIER Center and project 2 update. Presented at the U.S. EPA Clean Air Research Centers (CLARC) Annual Meeting, Cambridge, MA, June 21-22, 2012. |
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Presentation | Harkema JR. Interface of health effects caused by the CardioMetabolic Syndrome and exposures to air pollutant mixtures. Presented at the Society of Toxicology Webinar sponsored by the Risk Assessment and Mixtures Specialty Sections, April 10, 2013. |
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Presentation | Harkema JR. Toxicology pathology of the respiratory system. Presented at the Annual Meeting of the Latin American Society of Toxicologic Pathology, São Paulo, Brazil, April 13, 2014 (invited). |
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Presentation | Harkema JR. Interface of health effects caused by air pollution and the metabolic syndrome. Presented at the Biology Department Seminar, Calvin College, Grand Rapids, MI, April 25, 2014 (invited). |
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Presentation | Harkema JR. Nasal toxicity of inhaled chemical irritants. Presented at the 8th Annual CounterACT Network Research Symposium, Denver, CO, June 19, 2014 (invited). |
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Presentation | Harkema JR. Inhalation toxicology studies in air pollution research. Presented at the Annual Meeting of the Alleghany-Erie Regional Chapter of the Society of Toxicology, Morgantown, WV, May 15, 2014 (invited). |
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Presentation | Harkema JR. The intersection of two global health problems: air pollution and the metabolic syndrome. Presented at the West Michigan Clean Air Action Meeting, Grand Rapids, MI, May 2, 2014 (invited). |
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Presentation | Harkema JR. Mouse granulocytes: neutrophils and eosinophils in health and disease. Presented at the Understanding the Mouse Immune System: Relevance for the Study of Human Disease Workshop, Annual Conference of the American College of Veterinary Pathology, Atlanta, GA, November 8, 2014 (invited). |
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Presentation | Harkema JR. Toxicology exploring the health effects interface between air pollution and the metabolic syndrome. Presented at the 2014 Annual Conference of the Central States Society of Toxicology, Kansas City, MO, October 17, 2014 (invited). |
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Presentation | Harkema JR. Ozone, diabetes, and innate lymphoid cells: what’s the connection? Presented at the Lovelace Respiratory Research Institute, Albuquerque, NM, September 29, 2014 (invited). |
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Presentation | Harkema JR. GLACIER Center update. Presented at the U.S. EPA Clean Air Research Centers (CLARC) Annual Meeting, Atlanta, GA, September 2014 (invited). |
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Presentation | Harkema JR. Inhaled air pollutants and the respiratory and metabolic system response. Presented at the Experimental Biology Meeting, Boston, MA, March 29, 2015 (invited). |
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Presentation | Harkema JR, Allen KM, Williams KM, Jackson-Humbles DN, Lewandowski RP, Wagner JG. Inhaled ozone causes more severe lung lesions in hyperglycemic, insulin-resistant KKAy mice as compared to normoglycemic, insulin-sensitive C57BL/6 mice. Presented at the American Thoracic Society International Conference, Denver, CO, May 19, 2015. |
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Presentation | Hotchkiss IP, Allen K, Wagner JG, Morishita M, Lewandowski RP, Bramble LA, Dvonch JT, Harkema JR. Effects of high-fructose diet on nasal epithelial and inflammatory responses to inhaled ozone and ambient fine particles in rats. Presented at the Society of Toxicology 51st Annual Meeting and ToxExpo, San Francisco, CA, March 11-15, 2012. |
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Presentation | Kumagai K, Ong CB, Jackson-Humbles DN, Lewandowski RP, Wagner JG, Harkema JR. Ozone-induced eosinophilic rhinitis and nasal epithelial remodeling are dependent on innate lymphoid cells in mice. Presented at the Society of Toxicology 54th Annual Meeting and ToxExpo, San Diego, CA, March 22-26, 2015. |
R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2015) R834797C002 (Final) |
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Presentation | Ong Chee B, et al. Development of ozone-induced eosinophilic rhinitis in mice. Presented at the Annual Meeting of the Society of Toxicologic Pathology, Portland, OR, June 16-20, 2013. |
R834797 (2013) R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2013) |
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Presentation | Ong C, Allen K, Brandenberger C, Jackson-Humbles D, Bramble L, Lewandowski R, Wagner JG, Harkema JR. Development of eosinophilic rhinitis and nasal tissue remodeling in mice episodically exposed to ozone. Presented at the Society of Toxicology 53rd Annual Meeting and ToxExpo, Phoenix, AZ, March 23-27, 2014 (invited, abstract 2328). |
R834797 (2015) R834797 (Final) R834797C002 (2014) R834797C002 (Final) |
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Presentation | Wagner JG, Kamal AS, Allen K, Morishita M, Dvonch JT, Lewandowski RP, Fink GD, Harkema JR. Hypotensive and bradycardic responses to inhaled O3 and ambient fine particles are enhanced in rats on a high-fructose diet. Presented at the Society of Toxicology 51st Annual Meeting & ToxExpo, San Francisco, CA, March 11-15, 2012. |
R834797 (2015) R834797C002 (2012) R834797C002 (Final) |
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Presentation | Wagner JG, Kamal, AS, Allen K, Morishita M, Dvonch JT, Brook RD, Harkema JR. Decreases in blood pressure, heart rate, and heart rate variability in response to inhaled O3 and/or ambient fine particles are enhanced in rats on a high fructose diet. Presented at the American Thoracic Society International Conference, Moscone Convention Center, San Francisco, CA, May 18-23, 2012. |
R834797 (2015) R834797C002 (2012) R834797C002 (Final) |
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Presentation | Wagner JG. Cardiovascular toxicity of acute exposures to multipollutant atmospheres: results from field studies using a rodent model of the CardioMetabolic Syndrome. Presented at the EPA Work-In-Progress Webinar for the Clean Air Research Centers, January 2013. |
R834797 (2013) R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2013) R834797C002 (Final) |
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Presentation | Wagner JG. Interface of cardiovascular health effects and exposures to air pollutant mixtures caused by the metabolic syndrome. Presented at the University of Washington Environmental and Occupational Health Sciences Seminar Series, Seattle, WA, June 5, 2014 (invited). |
R834797 (2014) R834797 (Final) R834797C002 (2014) R834797C002 (Final) |
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Presentation | Wagner JG. Cardiometabolic interactions of diet and air pollution: field studies with multipollutant atmospheres. Presented at the Society of Toxicology 53rd Annual Meeting and ToxExpo, Phoenix, AZ, March 23-27, 2014 (invited, abstract 2071). |
R834797 (2015) R834797 (Final) R834797C002 (2014) R834797C002 (Final) |
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Presentation | Wagner JG, Kamal AS, Morishita M, Dvonch JT, Harkema JR, Rohr AC. PM2.5-induced tachycardia and hypertension in rats are linked to elemental carbon and specific temperature-resolved carbon fractions. Poster presented at the Society of Toxicology 53rd Annual Meeting and ToxExpo, Phoenix, AZ, March 23-27, 2014 (abstract 1240). |
R834797 (2015) R834797 (Final) R834797C002 (2014) R834797C002 (Final) |
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Presentation | Wagner JG, Das R, Allen K, Morishita M, Nan B, Mukherjee B, Harkema JR. Cardiovascular depression during inhalation exposure to a mixture of ozone and rural ambient fine particles (PM2.5) in rats on a high fructose diet. Poster presented at the American Thoracic Society 2014 International Conference, San Diego, CA, May 16-21, 2014 (abstract 1668). |
R834797 (2015) R834797 (Final) R834797C002 (2014) R834797C002 (Final) |
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Presentation | Wagner JG. Diet matters: cardiometabolic susceptibility to air pollution. Presented at the Institute for Risk Assessment Sciences, Center for Environmental Health Research, Utrecht University, Utrecht, The Netherlands, October 17, 2014 (invited). |
R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2015) R834797C002 (Final) |
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Presentation | Wagner JG. Source matters: cardiopulmonary and metabolic susceptibility to air pollution. Presented at the Department of Physiology and Pharmacology, School of Medicine, West Virginia University, Morgantown, WV, April 23, 2015 (invited). |
R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2015) R834797C002 (Final) |
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Presentation | Wagner JG, Das R, Morishita M, Nan B, Mukherjee B, Harkema JR. Distinct cardiovascular responses to traffic and urban industrial sources of ambient fine particulate matter in rats on a high fructose diet. Presented at the Society of Toxicology 54th Annual Meeting and ToxExpo, San Diego, CA, March 22-26, 2015. |
R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2015) R834797C002 (Final) |
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Presentation | Wagner JG, Das R, Lewandowski R, Morishita M, Nan B, Mukherjee B, Harkema JR. Cardiovascular responses in high fructose-fed rats exposed to mixtures of ozone and ambient fine particles (PM2.5) derived from urban and rural airsheds. Presented at the American Thoracic Society International Conference, Denver, CO, May 19, 2015. |
R834797 (2014) R834797 (2015) R834797 (Final) R834797C002 (2015) R834797C002 (Final) |
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Presentation | White K, Kumagai K and Harkema J. Innate Lymphoid Cells Mediate Type 2 Immunity in the Lungs of Mice Repeatedly Exposed to Ozone. Society of Toxicology Annual Meeting, March 14, 2016. |
R834797 (Final) R834797C002 (2016) R834797C002 (Final) |
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Presentation | Jackson-Humbles DN, Allen KM, Williams KM, Lewandowski RP, Wagner JG, Harkema JR. Inhaled ozone causes exaggerated pulmonary pathology in insulin-resistant, diabetes prone mice exposed to ozone. Presented at the Society of Toxicology Annual Meeting, New Orleans, LA, March 14, 2016. |
R834797 (Final) R834797C002 (2016) R834797C002 (Final) |
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Presentation | Harkema JR (invited). Strain-and Environment-Related Factors in Murine Models of Allergic Airway Disease. Society of Toxicologic Pathology Annual Symposium, San Diego, CA, June 29, 2016. |
R834797 (Final) R834797C002 (2016) R834797C002 (Final) |
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The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.