Clinical trial NCT03500458: Impact of Sleep Extension in Adolescents
Official title: Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
Sleep
Dietary Habits
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-18
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: 2 weeks after Baseline and 7 weeks after Baseline
measure: Change in Sleep Duration & Timing
timeFrame: At Baseline, 1 week after Baseline, and 6 weeks after Baseline
measure: Change in Physical activity
timeFrame: At Baseline, 1 week after Baseline and 6 weeks after Baseline
measure: Change in Dietary Intake
timeFrame: 1 week after Baseline and 6 weeks after Baseline
Secondary outcomes:
measure: Change in glycemic variability
timeFrame: 2 weeks after Baseline and 7 weeks after Baseline
measure: MTNR1B rs10830963 SNP
timeFrame: 2 weeks after Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado and University of Colorado Anschutz Medical Campus
name: Stacey Simon, PhD
role: PRINCIPAL_INVESTIGATOR
References: