Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

Diabetes Mellitus, Type 2 Clinical Trial

— REM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814512
• Other study ID #: 18-2396
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Lafayette	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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