SleepNCT00724087
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
A study testing 5.5-hour bedtime and 8.5-hour bedtime in people with Sleep and Sleep Deprivation, run by University of Chicago at 1 site in United States.
Trial summary
The use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Deprivation, Insulin Resistance
- What is being tested?
- 5.5-hour bedtime and 8.5-hour bedtime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- regular sleep habits
- BMI 20 to 27 kg/m2
- at least one parent, sibling or grandparent with type 2 diabetes
- must exercise regularly
Who cannot join
- active smoker
- night or shift work
- have highly variable sleep habits
- have a hormonal disorder
- have a sleep disorder
- have an active medical problem
Show all 9Show fewer
- women only: use of birth control pills
- women only: irregular menstrual periods or pregnancy
- use of medications/compounds that can disrupt sleep
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep, Energy Metabolism and Diabetes Risk.
The use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.
Read the detailed description
Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart. Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" in the sleep laboratory. During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus. At the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. Several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time. At the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.
- Conditions
- Sleep, Sleep Deprivation, Insulin Resistance, Type 2 Diabetes
- Being tested
- 5.5-hour bedtime, 8.5-hour bedtime
- Keywords
- short sleep duration, energy expenditure, insulin secretion, insulin action, lipid turnover, free fatty acids
- Medical subject headings
- Sleep Deprivation, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5.5-hour bedtimeOther
16 days with sleep allowed only during a 5.5-hour bedtime period at night
8.5-hour bedtimeOther
16 days with sleep allowed only during a 8.5-hour bedtime period at night
| Study group | Role | What they receive |
|---|---|---|
| 5.5-hour bedtime | Experimental | Not described Receives: Other: 5.5-hour bedtime |
| 8.5-hour bedtime | Experimental | Not described Receives: Other: 8.5-hour bedtime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy expenditure
Measured: during each bedtime intervention
Secondary outcomes (5)
Physical activity related energy expenditure
Measured: during each bedtime intervention
Total body insulin sensitivity
Measured: at the end of each bedtime intervention
First and second phase insulin secretion
Measured: at the end of each bedtime intervention
Endogenous glucose production
Measured: at the end of each bedtime intervention
Glycerol turnover and free fatty acid concentration
Measured: at the end of each bedtime intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2012
- Study completionMar 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Plamen D Penev, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724087
- Sponsor's protocol ID
- 16079A-S4
- Other IDs
- R01HL089637
- Status last verified
- Sep 2013
- First submitted
- 25 Jul 2008
- 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
- Sleep, Energy Metabolism and Diabetes Risk.
- ClinicalTrials.gov ID
- NCT00724087
- Acronym / sponsor ID
- 16079A-S4
- Conditions
- Sleep, Sleep Deprivation, Insulin Resistance, Type 2 Diabetes
- Keywords
- short sleep duration, energy expenditure, insulin secretion, insulin action, lipid turnover, free fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jul 2008 (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 use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.
Detailed description
Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart. Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" in the sleep laboratory. During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus. At the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. Several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time. At the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5.5-hour bedtime | Experimental | Other: 5.5-hour bedtime |
| 8.5-hour bedtime | Experimental | Other: 8.5-hour bedtime |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regular sleep habits
- BMI 20 to 27 kg/m2
- at least one parent, sibling or grandparent with type 2 diabetes
- must exercise regularly
Key exclusion criteria (9 listed)
- active smoker
- night or shift work
- have highly variable sleep habits
- have a hormonal disorder
- have a sleep disorder
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 |
|---|---|---|
| 5.5-hour bedtime16 days with sleep allowed only during a 5.5-hour bedtime period at night | Other | 5.5-hour bedtime |
| 8.5-hour bedtime16 days with sleep allowed only during a 8.5-hour bedtime period at night | Other | 8.5-hour bedtime |
Primary outcome
Total energy expenditure
Time frame: during each bedtime intervention
5 secondary outcomes
Physical activity related energy expenditure
Time frame: during each bedtime intervention
Total body insulin sensitivity
Time frame: at the end of each bedtime intervention
First and second phase insulin secretion
Time frame: at the end of each bedtime intervention
Endogenous glucose production
Time frame: at the end of each bedtime intervention
Glycerol turnover and free fatty acid concentration
Time frame: at the end of each bedtime intervention
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.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
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.
Plamen D Penev, MD, 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 5.5-hour bedtime and 8.5-hour bedtime in people with Sleep and Sleep Deprivation, 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 9 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?
Total energy expenditure (time frame: during each bedtime intervention). 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.