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 : November 17, 2021
|Condition or disease|
|Overweight and Obesity|
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|
|Estimated Enrollment :||120 participants|
|Observational Model:||Ecologic or Community|
|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 :||May 29, 2023|
|Estimated Study Completion Date :||May 29, 2023|
18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9.
- Insulin resistance [ Time Frame: Baseline ]Measured by a frequently sampled IV glucose tolerance test
- 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
- 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
Biospecimen Retention: None Retained
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
|Contact: Kelly G Baron, Ph.D.||email@example.com|
|Contact: Andrew Riverafirstname.lastname@example.org|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Andrew Rivera 801-585-0904 email@example.com|