Fitness and Sleep in People With Family History of Type 2 Diabetes.

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00721084
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
30
1
44
0.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Sleep, Energy Metabolism and Diabetes Risk
    Study Start Date :
    Jul 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Mar 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Total energy expenditure [during a 2-week observation period]

    Secondary Outcome Measures

    1. Maximal aerobic capacity [at the end of the observation period]

    2. Amount and distribution of body fat [at the end of the observation period]

    3. Physical activity related energy expenditure [during a 2-week observation period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Plamen D Penev, MD, PhD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00721084
    Other Study ID Numbers:
    • 16079A-S1
    • R01HL089637
    First Posted:
    Jul 23, 2008
    Last Update Posted:
    Sep 5, 2013
    Last Verified:
    Sep 1, 2013

    Study Results

    No Results Posted as of Sep 5, 2013