Sleep Extension or Regularity to Reduce Diabetes Risk in African American Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 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 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:
-
that participants can extend sleep by ~2 hours or adhere to sleep regularly within a 30min window at home for two weeks,
-
changes in glucose metabolism following the interventions and
-
changes in subjective hunger/appetite ratings and food intake
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 adults.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sleep Extension Participants that are in the sleep extension group will have their time in bed extended by 2 hours. This can include going to bed earlier and/or waking up later. |
Behavioral: Sleep Extension
Extending time in bed by 2 hours (going to bed earlier and/or waking up later)
|
| Experimental: Sleep Regularity Participants in the sleep regularity group will have consistent bedtimes (within 30min). |
Behavioral: Sleep Regularity
Consistent bedtimes (within 30min)
|
Outcome Measures
Primary Outcome Measures
- Sleep outcome measures- Sleep time [Baseline to Day 24]
A decrease in time to sleep onset from baseline to day 24 measured in time of day by Wrist Actigraphy Monitoring.
- Sleep Outcome- Wake time [Baseline to Day 24]
Change in wake time from baseline to day 24 measured in time of day by Wrist Actigraphy Monitoring.
- Sleep outcome- Sleep duration [Baseline to Day 24]
Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.
- Sleep Outcome- Regularity of sleep [Baseline to Day 24]
Change in regularity of sleep from baseline to day 24 measured by Wrist Actigraphy Monitoring. The value is from standard deviation of time of middle of the sleep period.
- Sleep Outcome- Sleep Efficiency [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.
- Change in glucose homeostasis after 24 days [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).
- Change in glucose homeostasis measured by Continuous Glucose Monitor (CGM) [Baseline to Day 24]
Mean Absolute Glucose (MAG - mg/dl), Coefficient of Variation (CV - mg/dl), Standard Deviation (SD-mg/dl), Area Under the Curve (AUC - mg/dl), Time Spent in Range (TIR - minutes), Continuous Overall Net Glycemic Action (CONGA - (mg/dl) per minutes) will be measured by Continuous Glucose Monitor (CGM).
Secondary Outcome Measures
- Changes from baseline through day 24 of novel Patient Reported Outcome instrument [Baseline to Day 24]
Detection of within-patient changes in sleep effects (sleepiness), appetite, mood, reported in a novel Patient-Reported Outcome instrument between baseline and Day 24.
- Glucose Homeostasis-First phase insulin response [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).
- Glucose Homeostasis-Oral disposition index (DIo) [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).
- Glucose Homeostasis- insulinogenic index [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).
- Weight in kg, measured from screening through study completion. [Screening to Day 24]
The change in weight values will be measured by in laboratory anthropometrics measurements.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
African American men and women
-
Age: greater than 21 and no older than 50 years.
-
Overweight [Body mass index (BMI) greater than or equal to 25 to 30 kg/m2]
-
Self-reported short sleep (less than 7hrs /night, sleep between 22:00-08:00, could sleep more if time permitted)
Exclusion Criteria: Anyone who does not meet the inclusion criteria will be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Chicago | Chicago | Illinois | United States | 60637 |
Sponsors and Collaborators
- University of Chicago
Investigators
- Principal Investigator: Erin Hanlon, Ph.D., University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB23-1060