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OpenTrials
Completed

NCT Number: NCT06128265

Sleep Extension or Regularity to Reduce Diabetes Risk

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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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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:

  • 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 and Black adults.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • African American or Black men and women
  • Age 21-50 years old
  • Overweight (BMI greater than or equal 25 kg/m2 and less than 35 kg/m2)
  • Self-reported short sleep (less than 7hrs/night, sleep between 22:00-08:00, and who indicate they could sleep more if they had the opportunity)
  • No previously diagnosed sleep disorders (including obstructive sleep apnea (OSA))
  • No existing diagnosis of diabetes
  • No history of endocrine dysfunction
  • No history of psychiatric, cardiovascular, or eating disorders, not having a gastro-intestinal disease that requires dietary adjustment,
  • Currently taking no medications (excluding statins and birth control)

Exclusion criteria

  • Drug and nicotine use
  • Habitual alcohol use of more than 2 drinks per day
  • Caffeine intake of more than 500 mg per day
  • Subjects who participated in medically managed weight loss program within the past year
  • Subjects who have undergone bariatric surgery,
  • Subjects who have dietary restrictions,
  • Subjects who worked night shifts, or crossed any time zones in the month prior to the study.
  • Sleep-disordered breathing (apnea-hypopnea index>15 events/hour) from an overnight at home sleep test (NOX)
  • Peri- and post-menopausal women will not be included.

Treatment and study plan

Sleep Extension

Behavioral

Extending time in bed by 2 hours (going to bed earlier and/or waking up later)

Sleep Regularity

Behavioral

Consistent bedtimes (within 30min)

Primary outcomes

  1. Sleep Onset Time

    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.

  2. Sleep Wake Time

    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.

  3. Sleep Duration

    Time frame: Baseline to Day 24

    Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.

  4. Standard Deviation of the Sleep Midpoint

    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.

  5. Sleep Efficiency

    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.

  6. Change in Glucose Homeostasis After 24 Days

    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).

  7. Primary Outcome 7A and B - CGM Glucose Variability Metrics (MAG and SD)

    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.

  8. Primary Outcome 7D - CGM: Continuous Overall Net Glycemic Action (CONGA)

    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.

  9. Primary Outcome 7E - CGM Area Under the Curve (AUC)

    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.

  10. Primary Outcome 7F - CGM Time in Range (TIR)

    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.

  11. Primary Outcome 7C - CGM Glucose Variability Metrics (CV)

    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.

Secondary outcomes

  1. Changes From Baseline Through Day 24 of Novel Patient Reported Outcome Instrument

    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.

  2. Glucose Homeostasis-First Phase Insulin Response

    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).

  3. Glucose Homeostasis-Oral Disposition Index (DIo)

    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).

  4. Glucose Homeostasis- Insulinogenic Index

    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).

  5. Weight in kg, Measured From Screening Through Study Completion.

    Time frame: Baseline to Day 24

    The change in weight values will be measured by in laboratory anthropometrics measurements.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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