Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

Not Applicable

Completed

• Conditions: Sleep; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Extended Sleep Intervention

• 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.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-24
• Study Start: 2019-03-21
• Primary Completion: 2022-04-20
• Study Completion: 2023-12-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extended Sleep Intervention (ES)	Extended Sleep Intervention	Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.

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

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Lafayette, Colorado, United States