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

Not Applicable

Recruiting

• Conditions: Sleep Hygiene; Sleep Deprivation; Eating Habit; Insufficient Sleep Syndrome; Overweight and Obesity; Type 2 Diabetes; Lifestyle Factors; Insulin Sensitivity; Sleep
• Interventions: Behavioral: Sleep Extension Intervention

• Registration Number: NCT06180837
• Lead Sponsor: University of Utah

Brief 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).

Detailed 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).

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-26
• Study Start: 2024-02-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Age: 18-45 years old; equal numbers of men and women
2. Body mass index (BMI): 27.5-34.9 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Sleep Extension Intervention	Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.

Primary Outcome Measures

Name	Time	Method
Total Plasma Ceramides	Immediately after the intervention	Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.
Insulin Sensitivity	Immediately after the intervention	Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.

Secondary Outcome Measures

Name	Time	Method
Circadian Phase (change from baseline)	Immediately after the intervention	dim-light melatonin onset quantified from salivary melatonin samples
Body Mass Index	Immediately after the intervention	Nurses will collect height and body weight using standard procedures.
Average (per week) nightly total sleep time (change from baseline)	Analyzed as change from baseline for each week of the ~8 week experimental segment	Wrist-actigraphy
Average (per week) sleep satisfaction change from baseline	Analyzed as change from baseline for each week of the ~8 week experimental segment	5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Average (per week) timing of food intake change from baseline	During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.	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
Average (per week) daytime alertness change from baseline	Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment	5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids.	Immediately after the intervention	Targeted metabolomics assay, 32 total metabolites.
Cardiac Event Risk Test 1 (CERT 1)	Immediately after the intervention	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.

Trial Locations

Locations (1)

College of Health Research Complex--University of Utah; 🇺🇸 Salt Lake City, Utah, United States