RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk

Quick Facts

Study Start:2024-02-12

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06180837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Christopher M Depner, PhD

CONTACT

801-581-2275

christopher.depner@utah.edu

Study Locations (Sites)

College of Health Research Complex--University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2028-01

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

sleep
insulin sensitivity

Additional Relevant MeSH Terms

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