Summary

Eligibility
for people ages 10-21 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Sri Nikhita Chimatapu (ucla)

Description

Summary

To study if continuous glucose monitors are feasible for use in children and adolescents with obesity.

Details

Various CGMs are approved by the U.S. Food and Drug Administration (FDA) for use in children and adults with diabetes. However, to date, little is known about how CGM technology can be integrated into weight management strategies for adolescents with obesity. No study to date has explored the effects of unblinded vs. blinded CGM use alone, without any other lifestyle modification recommendations. Thus, to address this question, this is a cross-over feasibility trial of blinded vs. unblinded CGM use in youth with obesity. This study hypothesizes that CGM will be a feasible and acceptable technology for youth with obesity, without diabetes, to utilize, and that access to daily glucose trends will facilitate positive changes in eating behavior and daily activity level compared to blinded CGM use. Thirty adolescents with obesity will be recruited into a six-week cross-over trial. All participants will be randomly assigned to either the blinded or unblinded group for three weeks. And then cross over to the other group for another three weeks. The primary endpoints are recruitment, retention, and adherence. While the secondary endpoints are glycemic variability, as captured on CGM, change in weight as an excess percentage of 95th percentile, sleep, dietary intake, physical activity, and eating behaviors.

Keywords

Pediatric Obesity, Obesity, Continuous glucose monitor

Eligibility

You can join if…

Open to people ages 10-21

- Age 10-21 years BMI >95th percentile

You CAN'T join if...

  • Previous diagnosis of Prader Willi Syndrome or hypothalamic obesity
  • Intellectual disability
  • Previous or planned bariatric surgery
  • Hemoglobin A1c >6.5 %
  • Current use of medication that impacts weight

Location

  • Pediatric Endocrinology Division, University of California accepting new patients
    Los Angeles California 90025 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06254768
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated