ObesityNCT00915707
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
A study testing Baseline, Sleep restriction and Reduced Sleep Quality in people with Obesity and Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Baseline, Sleep restriction and Reduced Sleep Quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2012
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight
- Healthy
- Normal sleep times
Who cannot join
- Sleep disorders
- Overweight
- Diabetes
- Other health conditions
- Excessive caffeine and alcohol intake
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.
- Being tested
- Baseline, Sleep restriction, Reduced Sleep Quality
- Keywords
- obesity, diabetes, risk, obesity, diabetes risk related to sleep
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
Subjects are allowed time in bed for sleep as their usual time at home.
Sleep restrictionOther
Subjects sleep is reduced to 4.5 hours in bed for 4 nights.
Reduced Sleep QualityOther
Subjects sleep quality is reduced for 4 nights.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Experimental | Subjects are tested under normal sleep conditions for carbohydrate metabolism and appetite regulation. Receives: Other: Baseline |
| Sleep restriction | Experimental | Subjects are tested under sleep restriction for carbohydrate metabolism and appetite regulation. Receives: Other: Sleep restriction |
| Reduced sleep quality | Experimental | Subjects are tested under a poor sleep quality condition for carbohydrate metabolism and appetite regulation. Receives: Other: Reduced Sleep Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915707
- Sponsor's protocol ID
- 14916B
- Status last verified
- Sep 2013
- First submitted
- 3 Jun 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- 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
- Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
- ClinicalTrials.gov ID
- NCT00915707
- Acronym / sponsor ID
- 14916B
- Keywords
- obesity, diabetes, risk, obesity, diabetes risk related to sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jun 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 is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | Experimental | Other: BaselineSubjects are tested under normal sleep conditions for carbohydrate metabolism and appetite regulation. |
| Sleep restriction | Experimental | Other: Sleep restrictionSubjects are tested under sleep restriction for carbohydrate metabolism and appetite regulation. |
| Reduced sleep quality | Experimental | Other: Reduced Sleep QualitySubjects are tested under a poor sleep quality condition for carbohydrate metabolism and appetite regulation. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal weight
- Healthy
- Normal sleep times
Key exclusion criteria (6 listed)
- Sleep disorders
- Overweight
- Diabetes
- Other health conditions
- Excessive caffeine and alcohol intake
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 |
|---|---|---|
| BaselineSubjects are allowed time in bed for sleep as their usual time at home. | Other | Baseline |
| Sleep restrictionSubjects sleep is reduced to 4.5 hours in bed for 4 nights. | Other | Sleep restriction |
| Reduced Sleep QualitySubjects sleep quality is reduced for 4 nights. | Other | Reduced sleep quality |
Primary outcome
Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality.
Time frame: 3 months
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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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.
Esra Tasali, MD 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 Baseline, Sleep restriction and Reduced Sleep Quality in people with Obesity 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 3 inclusion and 6 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?
Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality. (time frame: 3 months). 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.