An interventional study of Circadian Intervention in Cardiometabolic Syndrome, Type 2 Diabetes and Sleep, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for \~8 weeks. Both groups will have equal contact time with the study team.
Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Provided with general health information on diet and physical activity.
Circadian-based intervention focused on timing of light exposure and food intake.
Behavioral: Circadian Intervention
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Insulin sensitivity change from baseline
Oral Glucose Tolerance Test (OGTT), Matsuda Index
Time frame: Change from baseline to end of the ~8 week experimental segment
Timing of central circadian clock change from baseline
Quantified as dim-light melatonin onset from salivary melatonin samples
Time frame: Change from baseline to end of the ~8 week experimental segment
Plasma ceramides change from baseline
Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics
Time frame: Change from baseline to end of the ~8 week experimental segment
Average (per week) nightly total sleep time change from baseline
Analyzed by wrist-actigraphy
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Average (per week) sleep satisfaction change from baseline
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Average (per week) self-reported sleep duration change from baseline
Daily electronic sleep logs will be used to track sleep and waketimes during the ambulatory monitoring phases of the study
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Average (per week) timing of food intake change from baseline
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of 2 weekdays and 1 weekend day for baseline and final week of intervention
Time frame: Change from baseline to week 8 of the ~8 week experimental segment
Average (per week) daytime alertness change from baseline
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
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