Circadian Intervention to Improve Cardiometabolic Health

Type 2 Diabetes Clinical Trial

— TOCS  

Official title:

Timing of Circadian Synchronizers: The TOCS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943626
• Other study ID #: 22-60
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: March 2026

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: Christopher M Depner, PhD
• Phone: 801-581-2275
• Email: christopher.depner[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Eating Habit
• Insulin Resistance
• Insulin Sensitivity
• Lifestyle Factors
• Metabolic Syndrome
• Overweight
• Overweight and Obesity
• Sleep
• Sleep Hygiene
• Time Restricted Feeding
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	College of Health Research Complex--University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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