Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

NCT03814512 | Completed

• 1 other identifier: 18-2396
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Total Sleep Time

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

  up to 12 weeks

Study Arms (1)

Extended Sleep Intervention (ES)

EXPERIMENTAL

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

Interventions

Extended Sleep Intervention BEHAVIORAL

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.

Extended Sleep Intervention (ES)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Lafayette, Colorado, 80026, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study testing the intervention arm of the RCT. No control group.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: March 21, 2019
• Primary Completion: April 20, 2022
• Study Completion: December 31, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)