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Clinical Trials/NCT03814512
NCT03814512
Completed
Not Applicable

Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study

University of Colorado, Denver1 site in 1 country10 target enrollmentMarch 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
University of Colorado, Denver
Enrollment
10
Locations
1
Primary Endpoint
Change in Total Sleep Time
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2019
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Total Sleep Time

Time Frame: up to 12 weeks

The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention

Study Sites (1)

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