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Individual Differences in Diabetes Risk: Role of Sleep Disturbances

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00989976
First received: October 1, 2009
Last updated: December 5, 2014
Last verified: December 2014

October 1, 2009
December 5, 2014
February 2009
August 2014   (final data collection date for primary outcome measure)
diabetes risk as assessed by disposition index [ Time Frame: Dec. 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989976 on ClinicalTrials.gov Archive Site
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Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Sleep
  • Diabetes
  • Behavioral: normal sleep times
    8.5 h bedtimes
  • Behavioral: bedtime restriction
    4.5 h restricted bedtimes
  • 8.5 h sleep
    Subjects will have normal sleep times
    Intervention: Behavioral: normal sleep times
  • restricted bedtimes
    4.5 h bedtimes
    Intervention: Behavioral: bedtime restriction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:

    • age 18 to 29 years,
    • normal weight or modestly overweight (BMI ≤ 27 kg/m2 for women, BMI ≤ 28 kg/m2 for men),
    • normal findings on clinical examination, normal routine laboratory tests results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep disorders.
  • Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
  • An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal index >1/hour).
  • Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.

Exclusion Criteria:

  • Tobacco use.
  • Habitual alcohol use of more than 2 1 drink per day.
  • Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.

We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.

Both
18 Years to 29 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00989976
#16028A, DOD PR064727
No
Not Provided
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University of Chicago
University of Chicago
Not Provided
Principal Investigator: Eve Van Cauter, PhD University of Chicago
University of Chicago
December 2014

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