SleepNCT00721084
Fitness and Sleep in People With Family History of Type 2 Diabetes.
An observational study of Sleep and Physical Fitness, run by University of Chicago at 1 site in United States.
Trial summary
Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Physical Fitness, Type 2 Diabetes
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2012
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes
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
- no regular exercise habits
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
- for women: use of birth control pills
- for women: 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
Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. This study will test the hypothesis that individual differences in nighttime sleep duration are related to differences in the amount of energy used to perform activities of daily living and the overall level of physical fitness of the individual.
Read the detailed description
The study includes 2 weeks of monitoring of the participants' patterns of sleep and wakefulness at home. At the beginning of this period, all participants will undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal. At that time, all participants will also 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 at the beginning of the study and again 14 days later in order to measure the amount of energy that was used by them during this time. Participants will also wear small wristwatch-like activity monitors on their wrist and around their waist as they follow their usual everyday activities and sleep-wake schedules at home. The recordings from these monitors combined with daily sleep logs will be used to determine when the participants slept and when they were awake. On the last day of the study, the participants will undergo MRI measurements of the distribution of fat in their abdomen and complete a graded exercise test on a treadmill or stationary bicycle in order to determine what is the most strenuous level of exercise that they can perform. A medical doctor will supervise all study procedures that are done in the research laboratory.
- Conditions
- Sleep, Physical Fitness, Type 2 Diabetes
- Keywords
- short sleep duration, maximal aerobic capacity, body fat, visceral adiposity, activity-related energy expenditure, energy metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reduced sleep | Habitual sleep duration of less than 6 hours per night on most days of the week and total sleep of less than 43 hours per week. | |
| Reference sleep | Habitual sleep duration between 7 and 8.5 hours per night on most days of the week and total sleep of at least 53 hours per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy expenditure
Measured: during a 2-week observation period
Secondary outcomes (3)
Maximal aerobic capacity
Measured: at the end of the observation period
Amount and distribution of body fat
Measured: at the end of the observation period
Physical activity related energy expenditure
Measured: during a 2-week observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 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
- NCT00721084
- Sponsor's protocol ID
- 16079A-S1
- Other IDs
- R01HL089637
- Status last verified
- Sep 2013
- First submitted
- 21 Jul 2008
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Darukhanavala A, Booth JN 3rd, Bromley L, Whitmore H, Imperial J, Penev PD. Changes in insulin secretion and action in adults with familial risk for type 2 diabetes who curtail their sleep. Diabetes Care. 2011 Oct;34(10):2259-64. doi: 10.2337/dc11-0777. Epub 2011 Aug 11.
PubMed 21836106
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
- NCT00721084
- Acronym / sponsor ID
- 16079A-S1
- Conditions
- Sleep, Physical Fitness, Type 2 Diabetes
- Keywords
- short sleep duration, maximal aerobic capacity, body fat, visceral adiposity, activity-related energy expenditure, energy metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 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
- 23 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.
Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. This study will test the hypothesis that individual differences in nighttime sleep duration are related to differences in the amount of energy used to perform activities of daily living and the overall level of physical fitness of the individual.
Detailed description
The study includes 2 weeks of monitoring of the participants' patterns of sleep and wakefulness at home. At the beginning of this period, all participants will undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal. At that time, all participants will also 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 at the beginning of the study and again 14 days later in order to measure the amount of energy that was used by them during this time. Participants will also wear small wristwatch-like activity monitors on their wrist and around their waist as they follow their usual everyday activities and sleep-wake schedules at home. The recordings from these monitors combined with daily sleep logs will be used to determine when the participants slept and when they were awake. On the last day of the study, the participants will undergo MRI measurements of the distribution of fat in their abdomen and complete a graded exercise test on a treadmill or stationary bicycle in order to determine what is the most strenuous level of exercise that they can perform. A medical doctor will supervise all study procedures that are done in the research laboratory.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced sleep | – | –Habitual sleep duration of less than 6 hours per night on most days of the week and total sleep of less than 43 hours per week. |
| Reference sleep | – | –Habitual sleep duration between 7 and 8.5 hours per night on most days of the week and total sleep of at least 53 hours per week. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes
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
- no regular exercise habits
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.
Primary outcome
Total energy expenditure
Time frame: during a 2-week observation period
3 secondary outcomes
Maximal aerobic capacity
Time frame: at the end of the observation period
Amount and distribution of body fat
Time frame: at the end of the observation period
Physical activity related energy expenditure
Time frame: during a 2-week observation period
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.
- Derived from this study: PubMed 21836106Darukhanavala A, Booth JN 3rd, Bromley L, Whitmore H, Imperial J, Penev PD. Changes in insulin secretion and action in adults with familial risk for type 2 diabetes who curtail their sleep. Diabetes Care. 2011 Oct;34(10):2259-64. doi: 10.2337/dc11-0777. Epub 2011 Aug 11.
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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.
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?
An observational study of Sleep and Physical Fitness, 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 a 2-week observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00721084, which also lists 1 linked publication.
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.