Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

Type 2 Diabetes Clinical Trial

Official title:

Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180837
• Other study ID #: 164764
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• 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 determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Description:

A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted. Group allocation will be 1:1 and research staff and participants will be blinded until the conclusion of the baseline segment. The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night. Participants randomized to control will maintain their habitual sleep habits in their home environment. The intervention segment will last 8 weeks regardless of group assignment. Both groups will have equal contact time with the study team.

Prior to enrollment participants will complete a clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment). Throughout the study, sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides (targeted metabolomics assay) and insulin sensitivity (hyperinsulinemic-euglycemic clamp).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• 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., heart disease, kidney disease)

3. Clinically diagnosed diabetes or fasting plasma glucose =126 mg/dL or HbA1c =6.5%

4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.

5. Cancer that has been in remission less than 5 years

6. Pregnant/nursing, experiencing menopause or post-menopausal

7. Shift-work: current or history of within last year

8. Weight change: >10% of body weight over prior six months

9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program

10. Currently smoking

11. Alcohol intake>14 drinks per week or >3 drinks per day

Related Conditions & MeSH terms

• Eating Habit
• Hypersensitivity
• Insufficient Sleep Syndrome
• Insulin Resistance
• Insulin Sensitivity
• Lifestyle Factors
• Obesity
• Overweight
• Overweight and Obesity
• Sleep
• Sleep Deprivation
• Sleep Hygiene
• Type 2 Diabetes

Intervention

Behavioral:
• Sleep Extension Intervention
Sleep extension-based intervention focused on increasing time spent in bed by 2 hours per night by directly scheduling assigned bed and waketimes based on participant's individual schedules. Participants will receive weekly sleep tips and counseling on improving their sleep duration.

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	Total Plasma Ceramides	Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.	Immediately after the intervention
Primary	Insulin Sensitivity	Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.	Immediately after the intervention
Secondary	Average (per week) nightly total sleep time (change from baseline)	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) 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 two weekdays and one weekend day	During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
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)	Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Secondary	Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids.	Targeted metabolomics assay, 32 total metabolites.	Immediately after the intervention
Secondary	Circadian Phase (change from baseline)	dim-light melatonin onset quantified from salivary melatonin samples	Immediately after the intervention
Secondary	Body Mass Index	Nurses will collect height and body weight using standard procedures.	Immediately after the intervention
Secondary	Cardiac Event Risk Test 1 (CERT 1)	The Cardiac Event Risk Test 1 (CERT1) is used to evaluate the risk of major adverse cardiovascular events and can be calculated using data from our targeted metabolomics assay. The scale is from 0-12, 0 being the lowest risk and 12 being the highest level of risk.	Immediately after the intervention