View Clinical Trial (Medical Research Study)
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Sleep - Diabetes |
| Purpose: |
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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).
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00989976 |
| Primary Contact: |
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Principal Investigator Eve Van Cauter, PhD University of Chicago
Florian Chapotot, PhD Email: fchapotot@uchicago.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637 United States
Florian Chapotot, PhD Phone: 773-834-3437 Email: fchapotot@uchicago.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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