Impact of Sleep Extension in Adolescents

Sleep Clinical Trial

— SUNRISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03500458
• Other study ID #: 17-2095
• Secondary ID: K23DK117021R03DK
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Stacey Simon, PhD
• Phone: 720-777-5681
• Email: stacey.simon[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Sleep

Intervention

Behavioral:
• Sleep Extension
Participants will be asked to increase time in bed at least 1 hour more than baseline

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Sleep Duration & Timing	Assessed three times with a wrist-worn Actigraphy	At Baseline, 1 week after Baseline, and 6 weeks after Baseline
Primary	Change in Physical activity	Assessed three times with a triaxial thigh-worn ActivPal	At Baseline, 1 week after Baseline and 6 weeks after Baseline
Primary	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	Change in glycemic variability	Assessed two times with a continuous glucose monitor	2 weeks after Baseline and 7 weeks after Baseline
Secondary	MTNR1B rs10830963 SNP	Genotyping will be conducted on saliva samples	2 weeks after Baseline