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Circadian Timing, Information Processing and Energy Balance Study (TIME)

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ClinicalTrials.gov Identifier: NCT04759755
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : December 12, 2022
National Heart, Lung, and Blood Institute (NHLBI)
Rush University Medical Center
University of Illinois at Chicago
Information provided by (Responsible Party):
Kelly Glazer Baron, University of Utah

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.

Condition or disease
Overweight and Obesity

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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : January 31, 2025

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

Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: Baseline ]
    Measured by a frequently sampled IV glucose tolerance test

Secondary Outcome Measures :
  1. Eating behaviors [ Time Frame: 12 months ]
    Healthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)

  2. Delay discounting [ Time Frame: Baseline ]
    Measured by a 10 item adjusting delay discounting measure

Other Outcome Measures:
  1. Body mass index [ Time Frame: 12 months ]
    Height and weight will be measured at screening and 1 year follow-up

  2. Metabolic control [ Time Frame: 12 months ]
    HbA1c will be measured at screening and 12-month follow-up

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759755

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Contact: Kelly G Baron, Ph.D. 8015857588 kelly.baron@utah.edu
Contact: Andrea Baxter 8015850904 andrea.baxter@utah.edu

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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Andrea Baxter    801-585-0904    andrea.baxter@utah.edu   
Sponsors and Collaborators
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Rush University Medical Center
University of Illinois at Chicago
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Responsible Party: Kelly Glazer Baron, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04759755    
Other Study ID Numbers: 00117438
1R01HL141706-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available upon request
Time Frame: Data will be available within 1 year of completion of the study and will be available for 1 year
Access Criteria: Written request to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight