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

Not Applicable

Completed

• Conditions: Aging; Circadian Disruption; Sleep Restriction

• Registration Number: NCT02171273
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-03-31
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in glucose levels after standardized meal	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	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	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	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	Baseline day 2, at 3 weeks of exposure, and 1 week into recovery	Hourly blood samples for 24 hours

Secondary Outcome Measures

Name	Time	Method
Change in circadian phase and/or period	Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery	Via measurement of core body temperature and melatonin (salivary and plasma)
Changes in perception of pain, hunger and sleepiness	Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery	Daily questionnaires
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	Measurements on fasted blood samples
Change in resting metabolic rate	Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery	Indirect calorimetry, daily body weight, core body temperature
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	Blood samples collected every 4 hours for 48 hours
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	EKG, urinary catecholamines, fasting and postprandial blood samples for cortisol, epinephrine and norepinephrine
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	Bomb calorimetry on stool samples
Changes in sleep/wake architecture and brain electrical activity	Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery	Polysomnography during sleep and wake
Change in neurocognitive performance	Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery	Cognitive test battery presented via computer interface

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States