Impact of Sleep Extension in Adolescents

NCT03500458 | Active Not Recruiting

• 3 other identifiers: 17-2095K23DK117021R03DK131225
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get \<7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).

Conditions

Insulin Sensitivity; Sleep; Dietary Habits

Outcome Measures

Primary Outcomes (4)

• Change in Insulin Sensitivity

  Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.

  2 weeks after Baseline and 7 weeks after Baseline

• Change in Sleep Duration & Timing

  Assessed three times with a wrist-worn Actigraphy

  At Baseline, 1 week after Baseline, and 6 weeks after Baseline

• Change in Physical activity

  Assessed three times with a triaxial thigh-worn ActivPal

  At Baseline, 1 week after Baseline and 6 weeks after Baseline

• Change in Dietary Intake

  Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.

  1 week after Baseline and 6 weeks after Baseline

Secondary Outcomes (2)

• Change in glycemic variability

  2 weeks after Baseline and 7 weeks after Baseline

• MTNR1B rs10830963 SNP

  2 weeks after Baseline

Study Arms (2)

Typical Sleep

NO INTERVENTION

All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.

Sleep Extension

EXPERIMENTAL

Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation).

Behavioral: Sleep Extension

Interventions

Sleep Extension BEHAVIORAL

Participants will be asked to increase time in bed at least 1 hour more than baseline

Sleep Extension

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High school students between the age of 14-19 years
• have typically insufficient sleep, defined by ≤ 7 hours per night on school days
• BMI 5th-84th percentile for age and sex
• habitually sedentary (\< 3 hours of regular physical activity per week)
• Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

You may not qualify if:

• Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
• regular use of melatonin or other sleep aids
• a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
• Type 2 diabetes or prediabetes
• IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
• teens not enrolled in a traditional high school academic program (e.g., home school students)
• schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
• travel across more than two time zones in the 2 weeks prior to the study.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Feeding Behavior

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Officials

• Stacey Simon, PhD

  Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: October 15, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)