Aging Clinical Trial
Official title:
Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
Verified date | August 2019 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institute on Aging (NIA) |
United States,
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 |
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