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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171273
• Other study ID #: 2014-P-000243
• Secondary ID: 2P01AG009975-16A
• Status: Completed
• Phase: N/A
• Start date: March 31, 2014
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Circadian Disruption
• Sleep Restriction

Intervention

Behavioral:
• Circadian Disruption
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).
• Sleep Restriction
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).
• Control
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity	Euglycemic hyperinsulinemic clamp-assessed measure of insulin sensitivity	Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Primary	Changes in glucose levels after standardized meal	Frequent blood samples during and after standardized meal (breakfast), response of blood glucose levels	Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Primary	Change in insulin levels after standardized meal	Frequent blood samples during and after standardized meal (breakfast)	Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Primary	Change in 24h profiles of leptin	Hourly blood samples for 24 hours	Baseline day 2, during acute circadian misalignment (exposure day 3), and acute realignment (exposure day 7)
Primary	Change in 24h profiles of cortisol	Hourly blood samples for 24 hours	Baseline day 2, at 3 weeks of exposure, and 1 week into recovery
Secondary	Change in resting metabolic rate	Indirect calorimetry, daily body weight, core body temperature	Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Secondary	Change in circadian phase and/or period	Via measurement of core body temperature and melatonin (salivary and plasma)	Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary	Changes in sleep/wake architecture and brain electrical activity	Polysomnography during sleep and wake	Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary	Change in neurocognitive performance	Cognitive test battery presented via computer interface	Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary	Changes in perception of pain, hunger and sleepiness	Daily questionnaires	Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary	Change in inflammatory markers and wake-time hormone levels	Measurements on fasted blood samples	Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Secondary	Changes in daily patterns of gene expression, epigenetic or proteomic markers	Blood samples collected every 4 hours for 48 hours	Baseline day 2, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Secondary	Changes in measures of sympathovagal balance and autonomic function	EKG, urinary catecholamines, fasting and postprandial blood samples for cortisol, epinephrine and norepinephrine	Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Secondary	Change in nutrient absorption	Bomb calorimetry on stool samples	Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery