N/A
N=25
Sleep Timing and Insulin Resistance in Adolescents With Obesity
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02585830 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Dim Light Melatonin Onset and Offset — 21.33; 8.32 decimal hours
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dim Light Melatonin Onset and Offset |
21.33; 8.32 | — |
| PRIMARY Insulin Sensitivity |
2.9; 4.93 | — |
Summary
This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.
Eligibility Criteria
Inclusion Criteria
- High school students between the ages of 15-19
- BMI > 90th percentile
- Tanner stage 2 or greater
Exclusion Criteria
- Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics)
- Regular use of melatonin or sleep aids
- A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c > 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding
- IQ < 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes)
- Not enrolled in a traditional high school academic program (e.g., home school students)
- Night shift employment
- Travel across more than 2 time zones in the month prior to the study
Data sourced from ClinicalTrials.gov (NCT02585830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.