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

NCT06180837 | Recruiting DMC

• 1 other identifier: 164764
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

sleep; insulin sensitivity

Outcome Measures

Primary Outcomes (2)

• Total Plasma Ceramides

  Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.

  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.

  Immediately after the intervention

Secondary Outcomes (8)

• Average (per week) nightly total sleep time (change from baseline)

  Analyzed as change from baseline for each week of the ~8 week experimental segment

• Average (per week) sleep satisfaction change from baseline

  Analyzed as change from baseline for each week of the ~8 week experimental segment

• 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.

• Average (per week) daytime alertness change from baseline

  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.

  Immediately after the intervention

Study Arms (2)

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.

Behavioral: Sleep Extension Intervention

Interventions

Sleep Extension Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

College of Health Research Complex--University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance; Feeding Behavior; Sleep Hygiene; Diabetes Mellitus, Type 2; Sleep Deprivation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior, Animal; Behavior; Health Behavior; Diabetes Mellitus; Endocrine System Diseases; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Central Study Contacts

Christopher M Depner, PhD

CONTACT

801-581-2275; christopher.depner@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 26, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)