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

NCT04202731 | Terminated

• 1 other identifier: 19-0926
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Sleep duration

  Total sleep time at night in hours

  1 week

Study Arms (1)

Sleep Extension

EXPERIMENTAL

Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night.

Behavioral: PBS Study

Interventions

PBS Study BEHAVIORAL

Sleep extension intervention

Sleep Extension

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Jill L Kaar, PhD

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: November 20, 2019
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)