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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2023-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleep Extension

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

Group Type EXPERIMENTAL

PBS Study

Intervention Type BEHAVIORAL

Sleep extension intervention

Interventions

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PBS Study

Sleep extension intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes