Exploratory Pilot Study to Discover Genes That Restore the Molecular Circadian Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
研究概览
简要总结
The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General good health with the following conditions permissible
- •cardiovascular risk prevention, intake of low dose aspirin,
- •hypertension, intake of beta-blockers, ACE inhibitors, diuretics, calcium channel blockers
- •hypercholesterinemia, intake of statins
- •Cases: 70-85 years of age
- •Controls: 20-35 years of age
- •Patients must be able to read and understand English
- •Participants must sign the informed consent form
- •Participants must have a wrist-actigraphy-based average TST (total sleep time) ≥ 6 hours per night (measured over 7 consecutive days) occurring between 22:00 - 08:00
排除标准
- •Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation
- •Shift work, defined as recurring work between 22:00-05:00
- •History of clinically significant obstructive sleep apnea
- •Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after,
- •> 2 drinks of alcohol per day
- •Use of illicit drugs
研究组 & 干预措施
Young
Observational study without intervention
干预措施: Observational study without intervention (Other)
Elderly
Observational study without intervention
干预措施: Observational study without intervention (Other)
结局指标
主要结局
Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
时间窗: Time point 14:00 Hours
The primary endpoint will be the difference in phase angle in vitro between cycling fibroblasts and incubated with serum collected from cases (old adults) versus controls (young adults)
Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
时间窗: Time point 14:00 Hours
To determine if serum collected from young versus old healthy study participants have a differential effect on the expression of circadian rhythms in an in vitro culture of a fibroblast cell line
次要结局
- Physical activity(7 days)
- Sleep quantity(7 or more days)
- Chronotype(4 weeks)
- Acrophase(7 days)
- Sleep quality: actigraphy(7 days)
- Heart rate variability(24 hours)
- Ambient light exposure(7 days)
- Saliva cortisol(24 hours)