Back to resultsSleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Primary Purpose
Sleep
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PBS Study
Sponsored by
About this trial
This is an interventional treatment trial for Sleep
Eligibility Criteria
Inclusion Criteria:
- ages 14-19 years
- attending high 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
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep Extension
Arm Description
Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night.
Outcomes
Primary Outcome Measures
Sleep duration
Total sleep time at night in hours
Secondary Outcome Measures
Full Information
NCT ID
NCT04202731
First Posted
December 16, 2019
Last Updated
July 24, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04202731
Brief Title
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Official Title
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic impacted recruitment
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Extension
Arm Type
Experimental
Arm Description
Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night.
Intervention Type
Behavioral
Intervention Name(s)
PBS Study
Intervention Description
Sleep extension intervention
Primary Outcome Measure Information:
Title
Sleep duration
Description
Total sleep time at night in hours
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill L Kaar, PhD
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
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