NCT04202731TerminatedNot Applicable
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
University of Colorado, Denver2 sites in 1 country5 target enrollmentStarted: November 20, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Sleep duration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Sleep duration
Time Frame: 1 week
Total sleep time at night in hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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