Status:
COMPLETED
Circadian Timing, Information Processing and Energy Balance Study
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Rush University Medical Center
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-60 years
Brief Summary
This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic ri...
Detailed Description
The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadia...
Eligibility Criteria
Inclusion
- Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;
- able to read and write in English;
- BMI 25-39.9 (overweight, class one obesity, or class two obesity)
Exclusion
- High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;
- Diagnosed with diabetes or HbA1c\>7 at screening or taking medications known to affect glucose;
- History of cognitive or neurological disorders;
- Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;
- Unstable or serious medical illness;
- Overnight shift work or travel over 2 time zones in the past 2 months;
- Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;
- Current smoking;
- Daily caffeine intake \>300 mg;
- Pregnant or lactating;
- Currently on a restrictive of special diet.
Key Trial Info
Start Date :
May 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04759755
Start Date
May 29 2019
End Date
May 31 2024
Last Update
July 16 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108