- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721084
Fitness and Sleep in People With Family History of Type 2 Diabetes.
September 4, 2013 updated by: University of Chicago
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637
- The University Of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes
Description
Inclusion Criteria:
- regular sleep habits
- BMI 20 to 27 kg/m2
- at least one parent, sibling or grandparent with type 2 diabetes
- no regular exercise habits
Exclusion Criteria:
- active smoker
- night or shift work
- have highly variable sleep habits
- have a hormonal disorder
- have a sleep disorder
- have an active medical problem
- for women: use of birth control pills
- for women: irregular menstrual periods or pregnancy
- use of medications/compounds that can disrupt sleep
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total energy expenditure
Time Frame: during a 2-week observation period
|
during a 2-week observation period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal aerobic capacity
Time Frame: at the end of the observation period
|
at the end of the observation period
|
Amount and distribution of body fat
Time Frame: at the end of the observation period
|
at the end of the observation period
|
Physical activity related energy expenditure
Time Frame: during a 2-week observation period
|
during a 2-week observation period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Plamen D Penev, MD, PhD, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 21, 2008
First Submitted That Met QC Criteria
July 21, 2008
First Posted (Estimate)
July 23, 2008
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16079A-S1
- R01HL089637 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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