体重、睡眠和心脏健康
肥胖心血管风险的昼夜节律机制
A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk, with an additional focus on obesity. Specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors. It is intended to compare results in lean and obese individuals to determine if there are specific risks across the circadian cycle specific to obesity. Furthermore, using an exploratory approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.
研究概览
地位
详细说明
Overall, these studies will help us answer whether the circadian system predispose individuals to increased CV disease risk - particularly around the vulnerable morning period, and whether these risks differ with obesity. The results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the CV system that increase effectiveness while decreasing side effects, and may have particular relevance to management of CV risk in people with obesity.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Community sample
描述
Inclusion Criteria:
- Ages 25-65
- Lean and overweight (BMI 18.5-40kg/m2)
- Habitually sedentary
Exclusion Criteria:
- History of smoking/tobacco use
- Insomnia
- Moderate to severe obstructive sleep apnea.
- Prior shift work within 6 months prior to the study.
- Prescription medications
- Drugs of abuse
- Acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Normal Weight
Healthy lean controls [18.5<BMI<25 kg/m2 and waist circumference <94/80 cm (men/women respectively)] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
其他名称：
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Overweight
Healthy obese [30≤BMI<40 and waist circumference ≥94/80 (men and women respectively)] Healthy lean controls [18.5<BMI<25 kg/m2 and waist circumference <94/80 cm (men/women respectively)] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure (BP)
大体时间：5 Days
|
Measurements were collected up to 7 times per participant across the circadian cycle under constant conditions across 5 days. Resting BP and Exercise BP data were collected at the beginning of each of 7 wake periods in a supine position and where participants exercised at an intensity equivalent to brisk walking. Salivary melatonin was used to calculate the circadian phase marker using dim light melatonin onset (DLMO). All data were assigned a circadian phase relative to DLMO and binned into 4-hour (or 60-degree) intervals. In the statistical analysis, the weight group refers to normal or overweight, exercise condition refers to seated or exercising on the bike, and circadian phase refers to the center of the circadian bin. This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation. |
5 Days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Coronary Microvascular Blood Flux
大体时间：3 days
|
Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography. |
3 days
|
|
Flow Mediated Dilation (FMD)
大体时间：5 days
|
FMD to measure endothelial function. |
5 days
|
|
Heart Rate
大体时间：5 Days
|
Heart rate via 2-channel echocardiogram (ECG) |
5 Days
|
|
Epinephrine
大体时间：5 days
|
Venous Epinephrine to estimate sympathetic output |
5 days
|
|
Norepinephrine
大体时间：5 days
|
Venous Norepinephrine to estimate sympathetic output |
5 days
|
|
Cortisol
大体时间：5 days
|
Saliva cortisol to estimate sympathetic output |
5 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Beta-adrenergic Receptor Density (Exploratory Outcome)
大体时间：5 days.
|
Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging. |
5 days.
|
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Norepinephrine Reuptake Transport (Exploratory Outcome)
大体时间：5 days.
|
Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging. |
5 days.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Steven A Shea, PhD、Oregon Institute of Occupational Health Sciences
- 首席研究员：Jeanne M Link, PhD、OHSU Center for Radiochemistry Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00017489
- KL2TR002370 (美国 NIH 拨款/合同)
- R01HL140577 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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