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临床试验/NCT02171273
NCT02171273已完成不适用

Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Changes in glucose levels after standardized meal

研究概览

简要总结

The overall objectives of the proposed study are to examine the consequences of chronic circadian disruption and chronic sleep restriction on metabolic function in healthy adults.

详细描述

It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) when compared to young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality. An understanding of how the circadian and sleep homeostatic neurobiological processes responds to increasing homeostatic sleep pressure, and the effects of sleep restriction on metabolism at different ages, should provide information on the regulation of sleep and metabolism in aging, as well as direction for future treatments. In the present study, we will study the separate impacts of chronic sleep restriction (while minimizing circadian disruption) and chronic circadian disruption (while minimizing sleep disruption) and a poor diet on metabolism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults with conventional and regular sleep-wake timing
  • Non-smokers
  • Completion of medical, psychological, and sleep screening tests
  • Able to spend 37 consecutive days/nights in the laboratory

排除标准

  • History of neurological or psychiatric disorder
  • History of sleep disorder or regular use of sleep-promoting medication
  • Current prescription, herbal, or over-the-counter medication use
  • Traveling across 2 or more time zones within past 3 months
  • Donating blood within past 8 weeks
  • Worked night or rotating shift work within past 3 years
  • Hearing impairment
  • Drug or alcohol dependency

研究组 & 干预措施

Control (sleep extension)

Active Comparator

Following a baseline of adequate time in bed, study participants will continue to have adequate time in bed and opportunity for sleep during each 24-hour day, for 3 weeks.

干预措施: Control (Behavioral)

Chronic circadian disruption

Experimental

Following a baseline of adequate time in bed, study participants will spend 3 weeks on a daily jet-lag schedule (where each day is longer than 24 hours).

干预措施: Circadian Disruption (Behavioral)

Chronic sleep restriction

Experimental

Following a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks).

干预措施: Sleep Restriction (Behavioral)

结局指标

主要结局

Changes in glucose levels after standardized meal

时间窗: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery

Frequent blood samples during and after standardized meal (breakfast), response of blood glucose levels

Change in insulin levels after standardized meal

时间窗: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery

Frequent blood samples during and after standardized meal (breakfast)

Change in 24h profiles of leptin

时间窗: Baseline day 2, during acute circadian misalignment (exposure day 3), and acute realignment (exposure day 7)

Hourly blood samples for 24 hours

Change in insulin sensitivity

时间窗: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery

Euglycemic hyperinsulinemic clamp-assessed measure of insulin sensitivity

Change in 24h profiles of cortisol

时间窗: Baseline day 2, at 3 weeks of exposure, and 1 week into recovery

Hourly blood samples for 24 hours

次要结局

  • Change in circadian phase and/or period(Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery)
  • Changes in perception of pain, hunger and sleepiness(Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery)
  • Change in inflammatory markers and wake-time hormone levels(Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery)
  • Change in resting metabolic rate(Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery)
  • Changes in daily patterns of gene expression, epigenetic or proteomic markers(Baseline day 2, at 1 week and at 3 weeks of exposure, and 1 week into recovery)
  • Changes in measures of sympathovagal balance and autonomic function(Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery)
  • Change in nutrient absorption(Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery)
  • Changes in sleep/wake architecture and brain electrical activity(Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery)
  • Change in neurocognitive performance(Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Andrew Czeisler, MD, PhD

Baldino Professor of Sleep Medicine

Brigham and Women's Hospital

研究点 (2)

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