Type 2 Diabetes Clinical Trial
— TOCSOfficial title:
Timing of Circadian Synchronizers: The TOCS Study
NCT number | NCT05943626 |
Other study ID # | 22-60 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 13, 2023 |
Est. completion date | March 2026 |
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).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 25.0-34.9 kg/m2, 3. Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism 4. Shift-work: current or history of within last year 5. Weight change: >10% of body weight over prior six months 6. Experiencing menopause or post-menopausal 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 8. Currently pregnant or planning to become pregnant, or currently lactating. 9. Currently smoking 10. Alcohol intake >3 drinks per day or >14 drinks per week |
Country | Name | City | State |
---|---|---|---|
United States | College of Health Research Complex--University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin sensitivity change from baseline | Oral Glucose Tolerance Test (OGTT), Matsuda Index | Change from baseline to end of the ~8 week experimental segment | |
Secondary | Timing of central circadian clock change from baseline | Quantified as dim-light melatonin onset from salivary melatonin samples | Change from baseline to end of the ~8 week experimental segment | |
Secondary | Plasma ceramides change from baseline | Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics | Change from baseline to end of the ~8 week experimental segment | |
Secondary | Average (per week) nightly total sleep time change from baseline | Analyzed by wrist-actigraphy | Analyzed as change from baseline for each week of the ~8 week experimental segment | |
Secondary | Average (per week) sleep satisfaction change from baseline | 5 point likert scale on daily sleep log (1 = very good; 5 = very poor) | Analyzed as change from baseline for each week of the ~8 week experimental segment | |
Secondary | 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 | Analyzed as change from baseline for each week of the ~8 week experimental segment | |
Secondary | 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 | Change from baseline to week 8 of the ~8 week experimental segment | |
Secondary | Average (per week) daytime alertness change from baseline | 5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all) | Analyzed as change from baseline for each week of the ~8 week experimental segment |
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