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Individual Differences in Diabetes Risk: Role of Sleep Disturbances

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00989976
First received: October 1, 2009
Last updated: October 2, 2009
Last verified: October 2009
History of Changes

October 1, 2009
October 2, 2009
February 2009
December 2011   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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.
 
Recruiting
32
December 2011
December 2011   (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
Yes
Contact: Florian Chapotot, PhD fchapotot@uchicago.edu
United States
 
NCT00989976
#16028A, DOD PR064727
No
Eve Van Cauter, PhD, Professor, The University of Chicago
University of Chicago
Not Provided
Principal Investigator: Eve Van Cauter, PhD University of Chicago
University of Chicago
October 2009

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