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Completed

NCT Number: NCT04759755

Circadian Timing, Information Processing and Energy Balance Study

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Insulin resistance

    Time frame: Baseline

    Measured by a frequently sampled IV glucose tolerance test

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Rush University Medical Center
  • University of Illinois at Chicago

Registry information

Official study title

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

Acronym: TIME

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Feb 18, 2021
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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