Circadian Timing, Information Processing and Energy Balance Study

NCT04759755 | Completed Results

• 2 other identifiers: 001174381R01HL141706-01A1
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (HbA1c)

  Measured by the A1C now test, a point of care blood spot test

  Cross-sectional analysis at baseline

Study Arms (1)

Study participants

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• 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.

  PMID: 36717911 DERIVED

Biospecimen

Retention: NONE RETAINED

Saliva

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample was limited to overweight and obese participants only and screened for depression and sleep disorders.

Results Point of Contact

• Title: Dr. Kelly Baron
• Organization: University of Utah

kelly.baron@utah.edu

801-585-7588

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 18, 2021
• Study Start: May 29, 2019
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2024
• Last Updated: October 1, 2026
• Results First Posted: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)