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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00721084
First received: July 21, 2008
Last updated: September 4, 2013
Last verified: September 2013

July 21, 2008
September 4, 2013
July 2008
March 2012   (final data collection date for primary outcome measure)
Total energy expenditure [ Time Frame: during a 2-week observation period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721084 on ClinicalTrials.gov Archive Site
  • Maximal aerobic capacity [ Time Frame: at the end of the observation period ] [ Designated as safety issue: No ]
  • Amount and distribution of body fat [ Time Frame: at the end of the observation period ] [ Designated as safety issue: No ]
  • Physical activity related energy expenditure [ Time Frame: during a 2-week observation period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Fitness and Sleep in People With Family History of Type 2 Diabetes.
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes

  • Sleep
  • Physical Fitness
  • Type 2 Diabetes
Not Provided
  • 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.
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. Epub 2011 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721084
16079A-S1, R01HL089637
No
University of Chicago
University of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Plamen D Penev, MD, PhD University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP