Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Primary Purpose
Sleep, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
normal sleep times
bedtime restriction
Sponsored by
About this trial
This is an interventional basic science trial for Sleep focused on measuring Sleep, Diabetes Risk
Eligibility Criteria
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.
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
8.5 h sleep
restricted bedtimes
Arm Description
Subjects will have normal sleep times
4.5 h bedtimes
Outcomes
Primary Outcome Measures
diabetes risk as assessed by disposition index
Secondary Outcome Measures
Full Information
NCT ID
NCT00989976
First Posted
October 1, 2009
Last Updated
December 5, 2014
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00989976
Brief Title
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Official Title
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Diabetes
Keywords
Sleep, Diabetes Risk
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8.5 h sleep
Arm Type
Other
Arm Description
Subjects will have normal sleep times
Arm Title
restricted bedtimes
Arm Type
Other
Arm Description
4.5 h bedtimes
Intervention Type
Behavioral
Intervention Name(s)
normal sleep times
Intervention Description
8.5 h bedtimes
Intervention Type
Behavioral
Intervention Name(s)
bedtime restriction
Intervention Description
4.5 h restricted bedtimes
Primary Outcome Measure Information:
Title
diabetes risk as assessed by disposition index
Time Frame
Dec. 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eve Van Cauter, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
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Individual Differences in Diabetes Risk: Role of Sleep Disturbances
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