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OpenTrials
Completed

NCT Number: NCT00721084

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

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.

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total energy expenditure

    Time frame: during a 2-week observation period

Secondary outcomes

  1. Maximal aerobic capacity

    Time frame: at the end of the observation period

  2. Amount and distribution of body fat

    Time frame: at the end of the observation period

  3. Physical activity related energy expenditure

    Time frame: during a 2-week observation period

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep, Energy Metabolism and Diabetes Risk

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 23, 2008
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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