Glucose Metabolism DisordersNCT02583750
Snooze Control: Sleep Duration & Glucose Metabolism
A study testing OGTT after deprived sleep first and OGTT after sufficient sleep first in people with Glucose Metabolism Disorders, run by Xuewen Wang at 1 site in United States.
Trial summary
This project investigated how glucose metabolism differs due to sleep deprivation for three consecutive nights as compared to sufficient sleep for three nights by examining concentrations of glucose, insulin, and other factors involved in glucose metabolism. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- OGTT after deprived sleep first and OGTT after sufficient sleep first
- Type of treatment
- Pill or oral medicine, 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
- Jan 2014to Sep 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy college-aged males and females
- being minimally active
Who cannot join
- average more than 15,000 steps a day
- major health issues such as heart disease, diabetes
- taking medication to help with sleep or using a sleeping device
- any type of sleep problem such as sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Research Center University of South Carolina
Columbia, South Carolina, 29201
About this study
Official title: Snooze Control: The Effect of Sleep Deprivation on Glucose Metabolism
This project investigated how glucose metabolism differs due to sleep deprivation for three consecutive nights as compared to sufficient sleep for three nights by examining concentrations of glucose, insulin, and other factors involved in glucose metabolism.
Read the detailed description
16 participants were enrolled in the study (8 females, 8 males) aged 18-25 years. In order for the participants to qualify for the study, each had to wear a pedometer for a week before the study began to determine eligibility. Each participant came to the lab for an oral glucose tolerance test on a morning, following three nights when they were sleep deprived, and on another morning when they had three nights' sufficient sleep. The sequence of the oral glucose tolerance tests were randomly assigned. The sleep duration for participants was monitored by the readings of the sleep monitors that each participant wore. The oral glucose tolerance tests were performed after an overnight fast. A 20-gauge polyethylene catheter was placed in the antecubital vein for blood sampling. Blood samples were drawn once (0 min) before and 4 times (30, 60, 90, and 120 min) after a 75g glucose drink was consumed for the determination of plasma glucose, insulin, and concentrations of other factors. Each participant was told to continue their regular routine during the study period, including diet, caffeine usage, and exercise.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- OGTT after deprived sleep first, OGTT after sufficient sleep first
- Keywords
- glucose metabolism, sleep deprivation
- Medical subject headings
- Glucose Metabolism Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTT after deprived sleep firstBehavioural
Participants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights.
OGTT after sufficient sleep firstBehavioural
Participants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights.
| Study group | Role | What they receive |
|---|---|---|
| OGTT after deprived sleep first | Experimental | Participants came to the lab to perform the oral glucose tolerance test after three nights of sleep deprivation, then another test after three nights of sufficient sleep Receives: Behavioral: OGTT after deprived sleep first |
| OGTT after sufficient sleep first | Experimental | Participants came to the lab to perform the oral glucose tolerance test after three nights of sufficient sleep, then another test after three nights of deprived sleep Receives: Behavioral: OGTT after sufficient sleep first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentrations during oral glucose tolerance test
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuewen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuewen Wang, University of South Carolina
- Investigators
- Xuewen Wang, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583750
- Sponsor's protocol ID
- Pro00032421
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snooze Control: The Effect of Sleep Deprivation on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02583750
- Acronym / sponsor ID
- Pro00032421
- Conditions
- Glucose Metabolism Disorders
- Keywords
- glucose metabolism, sleep deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Xuewen WangUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Oct 2015 (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 project investigated how glucose metabolism differs due to sleep deprivation for three consecutive nights as compared to sufficient sleep for three nights by examining concentrations of glucose, insulin, and other factors involved in glucose metabolism.
Detailed description
16 participants were enrolled in the study (8 females, 8 males) aged 18-25 years. In order for the participants to qualify for the study, each had to wear a pedometer for a week before the study began to determine eligibility. Each participant came to the lab for an oral glucose tolerance test on a morning, following three nights when they were sleep deprived, and on another morning when they had three nights' sufficient sleep. The sequence of the oral glucose tolerance tests were randomly assigned. The sleep duration for participants was monitored by the readings of the sleep monitors that each participant wore. The oral glucose tolerance tests were performed after an overnight fast. A 20-gauge polyethylene catheter was placed in the antecubital vein for blood sampling. Blood samples were drawn once (0 min) before and 4 times (30, 60, 90, and 120 min) after a 75g glucose drink was consumed for the determination of plasma glucose, insulin, and concentrations of other factors. Each participant was told to continue their regular routine during the study period, including diet, caffeine usage, and exercise.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGTT after deprived sleep first | Experimental | Behavioral: OGTT after deprived sleep firstParticipants came to the lab to perform the oral glucose tolerance test after three nights of sleep deprivation, then another test after three nights of sufficient sleep |
| OGTT after sufficient sleep first | Experimental | Behavioral: OGTT after sufficient sleep firstParticipants came to the lab to perform the oral glucose tolerance test after three nights of sufficient sleep, then another test after three nights of deprived sleep |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy college-aged males and females
- being minimally active
Key exclusion criteria (4 listed)
- average more than 15,000 steps a day
- major health issues such as heart disease, diabetes
- taking medication to help with sleep or using a sleeping device
- any type of sleep problem such as sleep apnea
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 |
|---|---|---|
| OGTT after deprived sleep firstParticipants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights. | Behavioural | OGTT after deprived sleep first |
| OGTT after sufficient sleep firstParticipants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights. | Behavioural | OGTT after sufficient sleep first |
Primary outcome
Glucose concentrations during oral glucose tolerance test
Time frame: two hours
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 22 Oct 2015.
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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.
Xuewen Wang, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OGTT after deprived sleep first and OGTT after sufficient sleep first in people with Glucose Metabolism Disorders, run by Xuewen Wang 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 2 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 22 Oct 2015. 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?
Glucose concentrations during oral glucose tolerance test (time frame: two hours). 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 22 Oct 2015.