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

NCT ID: NCT00721084

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Sleep Physical Fitness Type 2 Diabetes

Keywords

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short sleep duration maximal aerobic capacity body fat visceral adiposity activity-related energy expenditure energy metabolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Plamen D Penev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21836106 (View on PubMed)

Other Identifiers

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R01HL089637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16079A-S1

Identifier Type: -

Identifier Source: org_study_id