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Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents (REM)

Primary Purpose

Sleep, Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extended Sleep Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extended Sleep Intervention (ES)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Total Sleep Time
The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention

Secondary Outcome Measures

Full Information

First Posted
January 22, 2019
Last Updated
February 2, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03814512
Brief Title
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents
Acronym
REM
Official Title
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a pilot study testing the intervention arm of the RCT. No control group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Sleep Intervention (ES)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Extended Sleep Intervention
Intervention Description
Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.
Primary Outcome Measure Information:
Title
Change in Total Sleep Time
Description
The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Children's Hospital Colorado
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

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