Cardiometabolic SyndromeTOCSNCT05943626
Circadian Intervention to Improve Cardiometabolic Health
A study testing Circadian Intervention in people with Cardiometabolic Syndrome and Type 2 Diabetes, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome, Type 2 Diabetes, Sleep
- What is being tested?
- Circadian Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to Jun 2027
- Phase
- Interventional
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years old; equal numbers of men and women
- Body mass index (BMI): 25.0-34.9 kg/m2,
- Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months
Who cannot join
- Clinically diagnosed sleep disorder or major psychiatric illness
- Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
- Use of prescription drugs or substances known to influence sleep or glucose metabolism
- Shift-work: current or history of within last year
- Weight change: >10% of body weight over prior six months
- Experiencing menopause or post-menopausal
Show all 10Show fewer
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently pregnant or planning to become pregnant, or currently lactating.
- Currently smoking
- Alcohol intake >3 drinks per day or >14 drinks per week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
College of Health Research Complex--University of Utah
Salt Lake City, Utah, 84112
Christopher Depner, 8015812275, sleepstudyparticipant@utah.edu
About this study
Official title: Timing of Circadian Synchronizers: The TOCS Study
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).
Read the detailed description
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.
- Conditions
- Cardiometabolic Syndrome, Type 2 Diabetes, Sleep, Time Restricted Feeding, Lifestyle Factors, Overweight and Obesity
- Being tested
- Circadian Intervention
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Intermittent Fasting, Overweight, Obesity, Insulin Resistance, Feeding Behavior, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Provided with general health information on diet and physical activity. |
| Intervention Group | Experimental | Circadian-based intervention focused on timing of light exposure and food intake. Receives: Behavioral: Circadian Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity change from baseline
Oral Glucose Tolerance Test (OGTT), Matsuda Index
Measured: Change from baseline to end of the ~8 week experimental segment
Secondary outcomes (7)
Timing of central circadian clock change from baseline
Quantified as dim-light melatonin onset from salivary melatonin samples
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Analyzed as change from baseline for each week of the ~8 week experimental segment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Depner, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943626
- Sponsor's protocol ID
- 22-60
- Acronym
- TOCS
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No