Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery

Not Applicable

Terminated

• Conditions: Sleep
• Interventions: Behavioral: PBS Study

• 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

Study Timeline

• Study Start: 2019-11-20
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Status Verified: 2023-07
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep Extension	PBS Study	Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night.

Primary Outcome Measures

Name	Time	Method
Sleep duration	1 week	Total sleep time at night in hours

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States