NCT00795249CompletedPhase 1
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kurume University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The number of circulating EMP
Study Overview
Brief Summary
The investigators hypothesized that circulating EMP is a useful surrogate marker of early stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP, from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were repeated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy individuals who have no coronary risk factors
Exclusion Criteria
- •hypertension
- •dyslipidemia
- •chronic kidney disease
- •liver dysfunction
- •obesity (BMI>25.0)
- •cerebrovascular disease
- •other severe systemic diseases (cancer, inflammatory diseases, etc)
Arms & Interventions
non-smoker
No Intervention
the age-matched healthy volunteers
smoker
Experimental
Individuals who have a habit of chronic smoking without any coronary risk factors
Intervention: smoking cessation (Behavioral)
Outcomes
Primary Outcomes
The number of circulating EMP
Time Frame: 2 weeks
Secondary Outcomes
- FMD(2 weeks)
Investigators
Study Sites (1)
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