Lifestyle FactorsNCT06180837
Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
A study testing Sleep Extension Intervention in people with Lifestyle Factors and Overweight and Obesity, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Factors, Overweight and Obesity, Insulin Sensitivity
- What is being tested?
- Sleep Extension Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to May 2028
- 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): 27.5-34.9 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., heart disease, kidney disease)
- Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
- Cancer that has been in remission less than 5 years
- Pregnant/nursing, experiencing menopause or post-menopausal
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- Shift-work: current or history of within last year
- Weight change: >10% of body weight over prior six months
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently smoking
- Alcohol intake>14 drinks per week or >3 drinks per day
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: Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
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).
Read the 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).
- Conditions
- Lifestyle Factors, Overweight and Obesity, Insulin Sensitivity, Eating Habit, Sleep Hygiene, Type 2 Diabetes
- Being tested
- Sleep Extension Intervention
- Keywords
- sleep, insulin sensitivity
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Feeding Behavior, Sleep Hygiene, Diabetes Mellitus, Type 2, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Extension InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Provided with general health information on diet and physical activity. |
| Intervention Group | Experimental | Sleep extension-based intervention focused on increasing time in bed by 2 hours per night. Receives: Behavioral: Sleep Extension Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Plasma Ceramides
Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.
Measured: Immediately after the intervention
Insulin Sensitivity
Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.
Measured: Immediately after the intervention
Secondary outcomes (8)
Average (per week) nightly total sleep time (change from baseline)
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) 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
Measured: During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
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: Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids.
Targeted metabolomics assay, 32 total metabolites.
Measured: Immediately after the intervention
Circadian Phase (change from baseline)
dim-light melatonin onset quantified from salivary melatonin samples
Measured: Immediately after the intervention
Body Mass Index
Nurses will collect height and body weight using standard procedures.
Measured: Immediately after the intervention
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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start12 Feb 2024
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle FactorsStudies 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
- 70 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
- NCT06180837
- Sponsor's protocol ID
- 164764
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No