Clinical trial NCT03814512: Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents
Official title: Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Diabetes Mellitus, Type 2
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study testing the intervention arm of the RCT. No control group.
Primary purpose: PREVENTION

Brief summary: The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

Detailed description: The specific aims of this feasibility study are to 1) examine the feasibility of recruitment and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into a sleep extension intervention; 2) assess adherence of a sleep extension intervention to increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and inadequate sleep; 3) determine estimates of mean and variability of potential intervention outcomes including metabolomic, body composition, and substrate oxidation. The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

This proposal is the first step to demonstrate feasibility in delivering the intervention in a research setting, measure the effect of the intervention on changing sleep duration, and examine changes in obesity-related IR metabolites that would lead to improved IR in an adolescent population with pre-diabetes. The long-term goal is to disseminate an effective and feasible T2D prevention program that can be sustainably implemented in clinical weight management settings.

Eligibility criteria: Inclusion Criteria:

1. High school students between the age of 13-19 years
2. BMI \>85th percentile for age and sex
3. Prediabetes defined as a HbA1c 5.7-6.4%
4. Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)

Exclusion Criteria:

1. Any medications that affect insulin resistance 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) or abnormal scores on sleep disorders screening measures
4. Type 2 diabetes (HbA1c ≥ 6.5%)
5. IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
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 extension protocol (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 Total Sleep Time
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: