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Circadian Timing, Information Processing and Energy Balance Study

Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04759755
Acronym
TIME
Enrollment
139
Registered
2021-02-18
Start date
2019-05-29
Completion date
2024-05-31
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Rush University Medical Center
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Insulin resistanceBaselineMeasured by a frequently sampled IV glucose tolerance test

Secondary

MeasureTime frameDescription
Eating behaviors12 monthsHealthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)
Delay discountingBaselineMeasured by a 10 item adjusting delay discounting measure

Other

MeasureTime frameDescription
Body mass index12 monthsHeight and weight will be measured at screening and 1 year follow-up
Metabolic control12 monthsHbA1c will be measured at screening and 12-month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026