N/A
N=120
Home Sleep and Circadian Phase: Mediators of Diabetes Risk
Sleep Deprivation · Diabetes · Circadian Dysregulation
Bottom Line
View on ClinicalTrials.gov: NCT01786564 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Oral Disposition Index — 11.5 None (Index) — p=.13
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Disposition Index |
11.5 | .13 |
Summary
The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.
Eligibility Criteria
Inclusion Criteria
- Ages 21-50 years
- BMI 15.
- History of cardiovascular event or disease (excluding controlled hypertension).
- Major psychiatric disorder or other major illness.
- Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).
- Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.
- Anyone who tests positive for common drugs of abuse.
- People with color blindness.
- People who have had Lasik eye surgery.
- People who work night shifts.
- Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.
Data sourced from ClinicalTrials.gov (NCT01786564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.