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Active, Not Recruiting

NCT Number: NCT03500458

Impact of Sleep Extension in Adolescents

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insulin Sensitivity Behavior Behavior, Animal Dietary Habits Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Sleep

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sleep Extension

Behavioral

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

Primary outcomes

  1. Change in Insulin Sensitivity

    Time frame: 2 weeks after Baseline and 7 weeks after Baseline

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

  2. Change in Sleep Duration & Timing

    Time frame: At Baseline, 1 week after Baseline, and 6 weeks after Baseline

    Assessed three times with a wrist-worn Actigraphy

  3. Change in Physical activity

    Time frame: At Baseline, 1 week after Baseline and 6 weeks after Baseline

    Assessed three times with a triaxial thigh-worn ActivPal

  4. Change in Dietary Intake

    Time frame: 1 week after Baseline and 6 weeks after Baseline

    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.

Secondary outcomes

  1. Change in glycemic variability

    Time frame: 2 weeks after Baseline and 7 weeks after Baseline

    Assessed two times with a continuous glucose monitor

  2. MTNR1B rs10830963 SNP

    Time frame: 2 weeks after Baseline

    Genotyping will be conducted on saliva samples

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents

Acronym: SUNRISE

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Apr 18, 2018
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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