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Clinical Trials/NCT04202731
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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