Status:
COMPLETED
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Lead Sponsor:
University of Chicago
Conditions:
Sleep
Diabetes
Eligibility:
All Genders
18-29 years
Phase:
NA
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 wav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00989976
Start Date
February 1 2009
End Date
August 1 2014
Last Update
December 8 2014
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637