NCT01590706已完成不适用
An Association Study of Characterizing Cognitive Decline and Functional Cardiac Senescence Profile Through the Association of Biomarkers and Clinical Outcomes in Healthy Middle Aged and Elderly Korean Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
研究概览
简要总结
- Although aging process appears to be generally characterized, investigators have been paid much attention to the specific target molecules, which leads to discover the clinical markers of the senescence. The present study is to investigate the clinical and biological profile of cognitive decline and functional cardiac senescence in healthy middle aged and elderly Korean volunteers.
- This study was conducted as a cross-sectional, single-center, comparative clinical study.
- Each volunteer was given informed consent for checking cognition and cardiac function. Blood and urine samples were collected to analyze genome, proteome, and metabolome to assess cognition and cardiac function of its muscle enzymes.
详细描述
- The protocol of this study was developed as the first assessment of the three to four series of clinical research on senescence.
- This design of the study is a non-interventional, single-center, single-visit design for investigating the cognitive decline and cardiac function including heart muscle enzyme activity, which have been considered one of the key points in aging process.
- Volunteers visit the study site during the screening period, informed consent for study participation and blood draw are given respectively, then, the eligibilities are met, participants visit the study site just once within two weeks.
- The participants undergo the following five procedures for 2-3 hours; out-patient visit,
- additional demographic interview including covariate factors (depression status, marital status
- vital sign check
- the questionnaire for cognitive function
- blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
- electrocardiogram (ECG), then they are discharged.
- Their safety follow-up is monitored in a week (± 1 day) by a phone-call from the study associates.
- To evaluate cognitive function, several cognitive batteries were used, 3MSE (Modified-Mini Mental State Examination), ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale); for cognitive biomarkers, Apolipoprotein E, Type-3 metabotropic glutamate receptors.
- To evaluate cardiac function including its enzyme activity: HRV (heart rate variability), CRP (c-reactive protein); Cardiac Troponin T.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects >= 45 and <= 80 years of age
- •who understands the study procedures signs informed consent forms
排除标准
- •who > 150 mmHg in systolic or < 95 mmHg in diastolic blood pressure
- •who > 110 mg/dl in fast glucose level
- •Smoking > 20 cigarettes/day
- •Alcohol > 3 units/day (1 unit = pure alcohol 10 milli Liter)
- •Caffeine > 5 cups of coffee or tea/day
研究者
Dal-Seok Oh, OMD, PhD
Senior Investigator
Korea Institute of Oriental Medicine
研究点 (1)
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