Overweight or ObesityNCT06128265
Sleep Extension or Regularity to Reduce Diabetes Risk
A study testing Sleep Extension and Sleep Regularity in people with Overweight or Obesity, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Sleep Extension and Sleep Regularity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Overweight or Obesity
- Being tested
- Sleep Extension, Sleep Regularity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
Extending time in bed by 2 hours (going to bed earlier and/or waking up later)
Sleep RegularityBehavioural
Consistent bedtimes (within 30min)
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension | Experimental | 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. Receives: Behavioral: Sleep Extension |
| Sleep Regularity | Experimental | Participants in the sleep regularity group will have consistent bedtimes (within 30min). Receives: Behavioral: Sleep Regularity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Time
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.
Measured: Baseline to Day 24
Sleep Wake Time
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.
Measured: Baseline to Day 24
Sleep Duration
Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.
Measured: Baseline to Day 24
Standard Deviation of the Sleep Midpoint
SD of midpoint is a measurement of sleep regularity. Calculated as the standard deviation of sleep midpoint over multiple nights.
Measured: Baseline to Day 24
Sleep Efficiency
Change in sleep efficiency from baseline to day 24 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.
Measured: Baseline to Day 24
Change in Glucose Homeostasis After 24 Days
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).
Measured: Baseline to Day 24
Primary Outcome 7A and B - CGM Glucose Variability Metrics (MAG and SD)
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.
Measured: Baseline to Day 24
Primary Outcome 7D - CGM: Continuous Overall Net Glycemic Action (CONGA)
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.
Measured: Baseline to Day 24
Primary Outcome 7E - CGM Area Under the Curve (AUC)
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.
Measured: Baseline to Day 24
Primary Outcome 7F - CGM Time in Range (TIR)
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.
Measured: Baseline to Day 24
Primary Outcome 7C - CGM Glucose Variability Metrics (CV)
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.
Measured: Baseline to Day 24
Secondary outcomes (5)
Changes From Baseline Through Day 24 of Novel Patient Reported Outcome Instrument
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.
Measured: Baseline to Day 24
Glucose Homeostasis-First Phase Insulin Response
Changes in first phase insulin response (ARIg=mu.i^-1.min) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).
Measured: Baseline to Day 24
Glucose Homeostasis-Oral Disposition Index (DIo)
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).
Measured: Baseline to Day 24
Glucose Homeostasis- Insulinogenic Index
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).
Measured: Baseline to Day 24
Weight in kg, Measured From Screening Through Study Completion.
The change in weight values will be measured by in laboratory anthropometrics measurements.
Measured: Baseline to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized and unblinded
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Hanlon, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128265
- Sponsor's protocol ID
- IRB23-1060
- Status last verified
- May 2026
- First submitted
- 7 Nov 2023
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A limited data set will be shared with a collaborator at the University of Northwestern.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Extension or Regularity to Reduce Diabetes Risk
- ClinicalTrials.gov ID
- NCT06128265
- Acronym / sponsor ID
- IRB23-1060
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized and unblinded
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: Sleep ExtensionParticipants 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. |
| Sleep Regularity | Experimental | Behavioral: Sleep RegularityParticipants in the sleep regularity group will have consistent bedtimes (within 30min). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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))
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ExtensionExtending time in bed by 2 hours (going to bed earlier and/or waking up later) | Behavioural | Sleep Extension |
| Sleep RegularityConsistent bedtimes (within 30min) | Behavioural | Sleep Regularity |
Primary outcome
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.
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.
Sleep Duration
Time frame: Baseline to Day 24
Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.
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.
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.
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).
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.
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.
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.
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.
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.
5 secondary outcomes
Changes From Baseline Through Day 24 of Novel Patient Reported Outcome Instrument
Time frame: Baseline to Day 24
Glucose Homeostasis-First Phase Insulin Response
Time frame: Baseline to Day 24
Glucose Homeostasis-Oral Disposition Index (DIo)
Time frame: Baseline to Day 24
Glucose Homeostasis- Insulinogenic Index
Time frame: Baseline to Day 24
Weight in kg, Measured From Screening Through Study Completion.
Time frame: Baseline to Day 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. A limited data set will be shared with a collaborator at the University of Northwestern.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Hanlon, Ph.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension and Sleep Regularity in people with Overweight or Obesity, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Time (time frame: Baseline to Day 24). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.