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NCT04202731 Clinical Trial

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

Sleep Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04202731
Other study ID # 19-0926
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 20, 2019
Est. completion date July 14, 2023

Study information
Verified date July 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date July 14, 2023
Est. primary completion date July 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 21 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• PBS Study
Sleep extension intervention

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep duration Total sleep time at night in hours 1 week
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