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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Insulin Resistance
• Sleep

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