SleepNCT00989378
Individual Differences in Diabetes Risk: Role of Slow WaveSleep
An observational study of Sleep and Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- What is being tested?
- baseline study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2010
- Phase
- Observational
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: normal healthy men and women
Who may be able to join
- healthy volunteers age 18-20 with a BMI < 27kg/m2 in women and < 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG
- only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)
- habitual bedtimes between 7.0-8.5 hours/night
- do not take medications will be recruited
Who cannot join
- women taking hormonal contraceptive therapy and pregnant women will be excluded
- individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded
- other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies
This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.
- Being tested
- baseline study
- Keywords
- sleep, insulin, diabetes, determine association between sleep characteristics and diabetes risk
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline studyBehavioural
normal bedtimes
| Study group | Role | What they receive |
|---|---|---|
| control | normal healthy men and women Receives: Behavioral: baseline study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Slow Wave Activity determines insulin sensitivity.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startNov 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989378
- Sponsor's protocol ID
- 16026A
- Status last verified
- Sep 2013
- First submitted
- 1 Oct 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies
- ClinicalTrials.gov ID
- NCT00989378
- Acronym / sponsor ID
- 16026A
- Keywords
- sleep, insulin, diabetes, determine association between sleep characteristics and diabetes risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 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.
This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | – | Behavioral: baseline studynormal healthy men and women |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- normal healthy men and women
Key inclusion criteria (4 listed)
- healthy volunteers age 18-20 with a BMI < 27kg/m2 in women and < 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG
- only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)
- habitual bedtimes between 7.0-8.5 hours/night
- do not take medications will be recruited
Key exclusion criteria (3 listed)
- women taking hormonal contraceptive therapy and pregnant women will be excluded
- individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded
- other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day
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 |
|---|---|---|
| baseline studynormal bedtimes | Behavioural | control |
Primary outcome
Amount of Slow Wave Activity determines insulin sensitivity.
Time frame: 2 days
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 5 Sep 2013.
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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, 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?
An observational study of 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 4 inclusion and 3 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 5 Sep 2013. 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?
Amount of Slow Wave Activity determines insulin sensitivity. (time frame: 2 days). 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 5 Sep 2013.