SleepNCT00989976
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
A study testing normal sleep times and bedtime restriction in people with Sleep and Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA). Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- What is being tested?
- normal sleep times and bedtime restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:
- age 18 to 29 years,
- normal weight or modestly overweight (BMI ≤ 27 kg/m2 for women, BMI ≤ 28 kg/m2 for men),
- normal findings on clinical examination, normal routine laboratory tests results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep disorders.
- Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
- An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal index >1/hour).
- Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.
Who cannot join
- Tobacco use.
- Habitual alcohol use of more than 2 1 drink per day.
- Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.
- We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).
- Being tested
- normal sleep times, bedtime restriction
- Keywords
- Sleep, Diabetes Risk
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal sleep timesBehavioural
8.5 h bedtimes
bedtime restrictionBehavioural
4.5 h restricted bedtimes
| Study group | Role | What they receive |
|---|---|---|
| 8.5 h sleep | Other | Subjects will have normal sleep times Receives: Behavioral: normal sleep times |
| restricted bedtimes | Other | 4.5 h bedtimes Receives: Behavioral: bedtime restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes risk as assessed by disposition index
Measured: Dec. 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989976
- Sponsor's protocol ID
- #16028A
- Other IDs
- DOD PR064727
- Status last verified
- Dec 2014
- First submitted
- 1 Oct 2009
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Leone VA, Frazier K, Kaur M, Chrisler EA, Sidebottom AM, Tai E, Tran V, Li S, Chang EB, Jones DP, Van Cauter E, Hanlon EC. Short-term sleep restriction in humans alters diurnal circulating metabolite profiles, including those of microbial origin. J Clin Invest. 2026 Mar 16;136(6):e189363. doi: 10.1172/JCI189363. eCollection 2026 Mar 16.
PubMed 41837293
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Diabetes Risk: Role of Sleep Disturbances
- ClinicalTrials.gov ID
- NCT00989976
- Acronym / sponsor ID
- #16028A
- Keywords
- Sleep, Diabetes Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8.5 h sleep | Other | Behavioral: normal sleep timesSubjects will have normal sleep times |
| restricted bedtimes | Other | Behavioral: bedtime restriction4.5 h bedtimes |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:
- Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
- An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal index >1/hour).
- Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.
Key exclusion criteria (4 listed)
- Tobacco use.
- Habitual alcohol use of more than 2 1 drink per day.
- Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.
- We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.
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 |
|---|---|---|
| normal sleep times8.5 h bedtimes | Behavioural | 8.5 h sleep |
| bedtime restriction4.5 h restricted bedtimes | Behavioural | restricted bedtimes |
Primary outcome
diabetes risk as assessed by disposition index
Time frame: Dec. 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 41837293Leone VA, Frazier K, Kaur M, Chrisler EA, Sidebottom AM, Tai E, Tran V, Li S, Chang EB, Jones DP, Van Cauter E, Hanlon EC. Short-term sleep restriction in humans alters diurnal circulating metabolite profiles, including those of microbial origin. J Clin Invest. 2026 Mar 16;136(6):e189363. doi: 10.1172/JCI189363. eCollection 2026 Mar 16.
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Healthy Adult Participants
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.
Eve Van Cauter, PhD 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 normal sleep times and bedtime restriction in people with Sleep and Diabetes, 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 7 inclusion and 4 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 8 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diabetes risk as assessed by disposition index (time frame: Dec. 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989976, which also lists 1 linked publication.
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 8 Dec 2014.