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The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.
Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers.
Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.
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| Measure | Description | Time Frame |
|---|---|---|
| The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers | To measure the level of smoking, at baseline the Fagerstrom nicotine dependence test and urinary cotinine are measured. For measurement of biomarkers of exposure, blood and 24 hour urine sampling are performed at V2. | At Visit 2 (up to14 days after Visit 1) |
| The level of CVD-related biomarkers in Asian smokers compared to non smokers | At Visit 2 (up to14 days after Visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy male and female Japanese smokers and non smokers, 30 years of age or older.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Tomoko Hasunuma, MD | Kitasato University, Tokyo, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26616146 | Result | Ludicke F, Magnette J, Baker G, Weitkunat R. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers. Biomarkers. 2015;20(6-7):411-21. doi: 10.3109/1354750X.2015.1096303. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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