Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents
- Conditions
- SleepDiabetes Mellitus, Type 2
- Registration Number
- NCT03814512
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- High school students between the age of 13-19 years
- BMI >85th percentile for age and sex
- Prediabetes defined as a HbA1c 5.7-6.4%
- Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)
- Any medications that affect insulin resistance 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) or abnormal scores on sleep disorders screening measures
- Type 2 diabetes (HbA1c ≥ 6.5%)
- IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
- 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 extension protocol (e.g. night shift employment)
- Travel across more than two time zones in the 2 weeks prior to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Total Sleep Time up to 12 weeks The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital Colorado
🇺🇸Lafayette, Colorado, United States
Children's Hospital Colorado🇺🇸Lafayette, Colorado, United States