Status:
COMPLETED
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents
Lead Sponsor:
University of Colorado, Denver
Conditions:
Sleep
Diabetes Mellitus, Type 2
Eligibility:
All Genders
13-19 years
Phase:
NA
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 p...
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 exten...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03814512
Start Date
March 21 2019
End Date
December 31 2023
Last Update
October 1 2024
Active Locations (1)
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1
Children's Hospital Colorado
Lafayette, Colorado, United States, 80026