Circadian Timing, Information Processing and Energy Balance Study

NCT ID: NCT04759755

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2024-05-31

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.

Conditions

Overweight and Obesity

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Study participants

18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kelly Glazer Baron

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Baron KG, Appelhans BM, Burgess HJ, Quinn L, Greene T, Allen CM. Circadian Timing, Information processing and Metabolism (TIME) study: protocol of a longitudinal study of sleep duration, circadian alignment and cardiometabolic health among overweight adults. BMC Endocr Disord. 2023 Jan 31;23(1):26. doi: 10.1186/s12902-023-01272-y.

Reference Type: DERIVED

PMID: 36717911 (View on PubMed)

Other Identifiers

1R01HL141706-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00117438

Identifier Type: -

Identifier Source: org_study_id