Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

Completed · Not applicable

Conditions studied: Sleep, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03814512

Run by

University of Colorado, Denver

People needed

10

Starts

2019-03-21

Expected to finish

2023-12-31

Last updated by the study team

2024-10-01

Who can join

Age: 13 and older, up to 19. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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