Clinical trial NCT00721084: Fitness and Sleep in People With Family History of Type 2 Diabetes.
Official title: Sleep, Energy Metabolism and Diabetes Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Physical Fitness
Type 2 Diabetes
Keywords: short sleep duration
maximal aerobic capacity
body fat
visceral adiposity
activity-related energy expenditure
energy metabolism
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total energy expenditure
timeFrame: during a 2-week observation period
Secondary outcomes:
measure: Maximal aerobic capacity
timeFrame: at the end of the observation period
measure: Amount and distribution of body fat
timeFrame: at the end of the observation period
measure: Physical activity related energy expenditure
timeFrame: during a 2-week observation period
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Plamen D Penev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.