This study will develop a simple index to measure how well the body uses insulin and overall heart and metabolic health in children and teens with obesity. The investigators will use data from wearable devices (like fitness trackers) and glucose monitors, along with lab tests, to learn how activity and glucose relate to metabolic problems.
This is a prospective cohort study to develop a metabolic index for insulin sensitivity and cardiometabolic fitness among children and adolescents with obesity. Adolescent patients undergoing evaluation for bariatric surgery or medical management of wight using GLP-1 agonist therapies will be consented for participation. Participants will be given a wearable fitness device and a continuous glucose monitor. Continuous monitoring will be carried out at three time points: preoperative or prior to starting medication, perioperative or after 3-4 weeks of GLP1 use during early treatment phase, and 3 months post-operatively or 3 months after dose stabilization or discontinuation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, United States
RECRUITINGPercent Reduction in BMI
assessment of change in BMI from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Body Weight
Change in body weight (kg)
Time frame: baseline through study completion, an average of 4 months
Fasting Glucose
change in fasting glucose levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Fasting Insulin
change in fasting insulin levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
HbA1c
change in HbA1c levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Lipid Panel
changes in lipid panel levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Liver Enzymes
changes in liver enzymes from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Obesity-related Comorbidities
Defined as resolution or improvement according to prespecified clinical criteria
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Time frame: baseline through study completion, an average of 4 months