HealthyNCT03437681
Tissue-specific Effects of Insufficient Sleep
A study testing Insufficient sleep in people with Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Insufficient sleep
- 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
- 12 Feb 2018to 30 Dec 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, lean participants.
- No regular physical activity (<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
- Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
- Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.
Who cannot join
- Current or history of any clinically significant medical, psychiatric, or sleep disorder.
- Use or history of any drugs, medications, supplements, caffeine, and alcohol.
- Current or history of shiftwork in six months prior to laboratory study.
- Travel more than one time zone in three weeks prior to laboratory study.
- Blood donation in the 30 days prior to inpatient study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.
Read the detailed description
Participants will stay in the hospital for 6 days and will not be able to leave. Sleep habits will be measured for 7 days before the study. A research diet that is designed to maintain weight will be provided for 3 days before the study and during the study. Multiple tests will be performed, including metabolic testing and muscle and fat biopsies, both when participants first arrive and have had normal sleep and again after 4 nights of only 5 hours time in bed. The visit takes place at the Clinical Translational Research Center (CTRC) at the University of Colorado Denver, Anschutz Medical campus. It will take approximately 2 weeks to complete this study.
- Conditions
- Healthy
- Being tested
- Insufficient sleep
- Keywords
- Sleep, Blood Sugar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufficient sleepBehavioural
Four days of insufficient sleep
| Study group | Role | What they receive |
|---|---|---|
| Insufficient sleep | Experimental | Each participant will receive 4 nights of insufficient sleep. Receives: Behavioral: Insufficient sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.
Measured: One week
Secondary outcomes (5)
Changes in macrovascular function
Macrovascular function will be assessed with flow-mediated dilation
Measured: One week
Changes in microvascular function
Macrovascular function will be assessed with EndoPAT
Measured: One week
Changes in cognitive abilities
Cognitive computer tests performed during study
Measured: One week
Changes in circadian rhythms
Salivary dim-light melatonin offset will be assessed
Measured: One week
Changes in metabolic tissue function
Tissue biopsies will be performed
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start12 Feb 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The project is a within-subject consecutive design examining 18 healthy individuals after baseline and after 4 nights of insufficient sleep.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josiane L. Broussard, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437681
- Sponsor's protocol ID
- 17-0533
- Status last verified
- Nov 2023
- First submitted
- 6 Feb 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue-specific Effects of Insufficient Sleep
- ClinicalTrials.gov ID
- NCT03437681
- Acronym / sponsor ID
- 17-0533
- Conditions
- Healthy
- Keywords
- Sleep, Blood Sugar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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 plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.
Detailed description
Participants will stay in the hospital for 6 days and will not be able to leave. Sleep habits will be measured for 7 days before the study. A research diet that is designed to maintain weight will be provided for 3 days before the study and during the study. Multiple tests will be performed, including metabolic testing and muscle and fat biopsies, both when participants first arrive and have had normal sleep and again after 4 nights of only 5 hours time in bed. The visit takes place at the Clinical Translational Research Center (CTRC) at the University of Colorado Denver, Anschutz Medical campus. It will take approximately 2 weeks to complete this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The project is a within-subject consecutive design examining 18 healthy individuals after baseline and after 4 nights of insufficient sleep.
| Arm | Type | Receives |
|---|---|---|
| Insufficient sleep | Experimental | Behavioral: Insufficient sleepEach participant will receive 4 nights of insufficient sleep. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, lean participants.
- No regular physical activity (<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
- Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
- Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.
Key exclusion criteria (5 listed)
- Current or history of any clinically significant medical, psychiatric, or sleep disorder.
- Use or history of any drugs, medications, supplements, caffeine, and alcohol.
- Current or history of shiftwork in six months prior to laboratory study.
- Travel more than one time zone in three weeks prior to laboratory study.
- Blood donation in the 30 days prior to inpatient study.
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 |
|---|---|---|
| Insufficient sleepFour days of insufficient sleep | Behavioural | Insufficient sleep |
Primary outcome
Change in insulin sensitivity
Time frame: One week
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.
5 secondary outcomes
Changes in macrovascular function
Time frame: One week
Changes in microvascular function
Time frame: One week
Changes in cognitive abilities
Time frame: One week
Changes in circadian rhythms
Time frame: One week
Changes in metabolic tissue function
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Full list of publicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Josiane L. Broussard, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insufficient sleep in people with Healthy, run by University of Colorado, Denver 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 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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?
Results are not available in the source record.
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?
Change in insulin sensitivity (time frame: One week). 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 30 Nov 2023.