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

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Sleep

Treatments: Behavioral: PBS Study

Study type: Interventional

Funder types: Other

Identifiers

NCT04202731

19-0926

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Sleep Extension

Experimental group

Description:

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

Treatment:

Behavioral: PBS Study