University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT06128265
The goal of this study is to identify an intervention that improves sleep health and consequently metabolic health by examining whether sleep extension or enforced regularity in short sleepers will have beneficial effects on diabetes and obesity risk.
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Notify Me21 year–50 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
Numerous studies of restricted sleep have revealed insufficient sleep as a novel risk factor for metabolic disease. Specifically, it has been reported that insufficient sleep resulted in impairments in appetite regulation, energy intake, glucose tolerance, and insulin sensitivity. Further, recent studies have begun to reveal that the regularity of sleep timing may also impact metabolic health, in that increased sleep variability was associated with greater cardio-metabolic risk. Alternatively, only a few studies have explored whether sleep extension could be beneficial to metabolic outcomes, and no studies have focused on improved regularity or racial disparities. These studies have revealed improvements in glucose metabolism and caloric intake in predominantly non-Hispanic White individuals. Therefore, in this pilot study, we seek to examine whether sleep extension or enforced regularity can improve diabetes and obesity risk in a population known to be differentially impacted by sleep deficiency and metabolic disease, short sleeping African American and Black adults.
The investigator proposes to first assess sleep duration, food intake, ratings of hunger/appetite and reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance in short sleeping overweight African American and Black adults during a baseline/habitual sleep assessment. Participants will then be randomized to one of two different 14-day sleep interventions: sleep extension or sleep regularity. Following the intervention, assessments of food intake, ratings of hunger/appetite and reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance will be repeated. The goal of this pilot project is to demonstrate feasibility of our study design, particularly effectively impacting sleep in the home. The aims of this pilot study are to demonstrate:
This experimental approach is expected to reveal novel and important interventions that can have a beneficial impact on the risk of diabetes and obesity in an understudied population that suffers from increased risk, short sleeping overweight African American and Black adults.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extending time in bed by 2 hours (going to bed earlier and/or waking up later)
Consistent bedtimes (within 30min)
Time frame: Baseline to Day 24
Change in sleep onset time (minutes from midnight). Sleep onset time was recorded in hh:mm:ss format and converted to minutes from midnight for analysis.
Time frame: Baseline to Day 24
Change in wake time (minutes from midnight). Sleep wake time was recorded in hh:mm:ss format and converted to minutes from midnight for analysis.
Time frame: Baseline to Day 24
Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.
Time frame: Baseline to Day 24
SD of midpoint is a measurement of sleep regularity. Calculated as the standard deviation of sleep midpoint over multiple nights.
Time frame: Baseline to Day 24
Change in sleep efficiency from baseline to day 24 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.
Time frame: Baseline to Day 24
The Matsuda Index of whole body insulin sensitivity, the homeostasis model assessment (HOMA) measures beta cell function and insulin resistance will be measured by Oral glucose tolerance test (OGTT).
Time frame: Baseline to Day 24
This outcome includes two CGM-derived glucose variability metrics: Mean Absolute Glucose (MAG) and Standard Deviation (SD). All values are expressed in mg/dL. Change from Baseline to Day 24 was calculated.
Time frame: Baseline to Day 24
CONGA was calculated from continuous glucose monitoring data as a measure of short-term glycemic variability. Values were expressed in mg/dL per minute. Change from Baseline to Day 24 was calculated.
Time frame: Baseline to Day 24
AUC was derived from continuous glucose monitoring data to quantify total glycemic exposure over the monitoring period. Values were expressed in mg*hr/dL. Change from Baseline to Day 24 was calculated.
Time frame: Baseline to Day 24
TIR was calculated as the total number of minutes glucose values remained within the target glycemic range based on continuous glucose monitoring. Values were expressed in minutes. Change from Baseline to Day 24 was calculated.
Time frame: Baseline to Day 24
This outcome includes CGM-derived glucose variability metric: Coefficient of Variation (CV) expressed in percentage of coefficient of variation. Change from Baseline to Day 24 was calculated.
Time frame: Baseline to Day 24
Within-subject changes in sleep effects (sleepiness), appetite, mood, reported between baseline and Day 24. For sleepiness, the self-administered Epworth Sleepiness scale was used, participants rate the likelihood of falling asleep in eight common daily situations from 0 = never to 3 = high chance, scores range from 0 to 24, with higher scores denoting more sleepiness. Appetite and mood (vigor and affect) was administered via visual analog scale ranging from 0 to 10 on subscales. Appetite final score was the sum of 7 separate craving/food category assessments, with the total scoring ranging from 0-70 with higher scores denoting greater appetite. Vigor and affect are both derived from 4 different assessments, scores can range from 0-10. Vigor is calculated by subtracting sub-scales effort, weary, and sleepy from alert/4. Affect is calculated by subtracting sad and tense from the sum of happy and calm/4. For both, higher scores denote greater vigor and affect.
Time frame: Baseline to Day 24
Changes in first phase insulin response (ARIg=mu.i^-1.min) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).
Time frame: Baseline to Day 24
Changes in oral disposition index (DIo) from baseline to Day 24 measured in (SI x ARIg = [(mu/l)^-1.min^-1] * [mu.l^-1.min]) by oral glucose tolerance test (OGTT).
Time frame: Baseline to Day 24
Changes in insulinogenic index (change in plasma insulin/change in plasma glucose from 0-30 minutes = (pmol/L)/(mg/dL)) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).
Time frame: Baseline to Day 24
The change in weight values will be measured by in laboratory anthropometrics measurements.
University of Chicago
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