Overweight and ObesityTIMENCT04759755
Circadian Timing, Information Processing and Energy Balance Study
An observational study of Overweight and Obesity, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 31 May 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes
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.
Read the 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
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | 18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (HbA1c)
Measured by the A1C now test, a point of care blood spot test
Measured: Cross-sectional analysis at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start29 May 2019
- Primary completion31 Mar 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Rush University Medical Center, University of Illinois at Chicago
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759755
- Sponsor's protocol ID
- 00117438
- Other IDs
- 1R01HL141706-01A1
- Acronym
- TIME
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2021
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request
Publications
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.
PubMed 36717911