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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Sleep
• Intervention / Treatment: Behavioral: Extended Sleep Intervention

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Extended Sleep Intervention (ES); 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.

Behavioral: Extended Sleep Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Sleep Time	The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention	up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: 18-2396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No