Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Not Applicable
Terminated
- Conditions
- Sleep
- Registration Number
- NCT04202731
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- ages 12-21 years
- attending high school or middle school (peak period for insufficient and delayed sleep)
- completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
- All must also be Tanner Stage 5
Exclusion Criteria
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
- HbA1c ≥6.5%
- intelligence quotient (IQ) <70 or severe mental illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sleep duration 1 week Total sleep time at night in hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Hospital Colorado🇺🇸Aurora, Colorado, United States