We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759755
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : December 12, 2022
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date February 13, 2021
First Posted Date February 18, 2021
Last Update Posted Date December 12, 2022
Actual Study Start Date May 29, 2019
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2021)
Insulin resistance [ Time Frame: Baseline ]
Measured by a frequently sampled IV glucose tolerance test
Original Primary Outcome Measures
 (submitted: February 17, 2021)
Insulin resistance [ Time Frame: 0 months ]
Measured by a frequently sampled IV glucose tolerance test
Change History
Current Secondary Outcome Measures
 (submitted: February 17, 2021)
  • Eating behaviors [ Time Frame: 12 months ]
    Healthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)
  • Delay discounting [ Time Frame: Baseline ]
    Measured by a 10 item adjusting delay discounting measure
Original Secondary Outcome Measures
 (submitted: February 17, 2021)
  • Eating behaviors [ Time Frame: 12 months ]
    Healthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)
  • Delay discounting [ Time Frame: 0 months ]
    Measured by a 10 item adjusting delay discounting measure
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2021)
  • Body mass index [ Time Frame: 12 months ]
    Height and weight will be measured at screening and 1 year follow-up
  • Metabolic control [ Time Frame: 12 months ]
    HbA1c will be measured at screening and 12-month follow-up
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Circadian Timing, Information Processing and Energy Balance Study
Official Title Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes
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.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Saliva
Sampling Method Non-Probability Sample
Study Population community sample
Condition Overweight and Obesity
Intervention Not Provided
Study Groups/Cohorts Study participants
18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2022)
140
Original Estimated Enrollment
 (submitted: February 17, 2021)
120
Estimated Study Completion Date January 31, 2025
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kelly G Baron, Ph.D. 8015857588 kelly.baron@utah.edu
Contact: Andrea Baxter 8015850904 andrea.baxter@utah.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04759755
Other Study ID Numbers 00117438
1R01HL141706-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Current Responsible Party Kelly Glazer Baron, University of Utah
Original Responsible Party Same as current
Current Study Sponsor University of Utah
Original Study Sponsor Same as current
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Rush University Medical Center
  • University of Illinois at Chicago
Investigators Not Provided
PRS Account University of Utah
Verification Date December 2022