Clinical trial NCT04759755: Circadian Timing, Information Processing and Energy Balance Study
Official title: Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Rush University Medical Center
name: University of Illinois at Chicago
First posted: 2021-02-18
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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 risk factors.

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 circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.

In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Insulin resistance
timeFrame: Baseline
Secondary outcomes:
measure: Eating behaviors
timeFrame: 12 months
measure: Delay discounting
timeFrame: Baseline
Other outcomes:
measure: Body mass index
timeFrame: 12 months
measure: Metabolic control
timeFrame: 12 months
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: