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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery | Experimental | Adolescent patients in the Adolescent Bariatric Program at Stanford Children's undergoing bariatric surgery will undergo continuous glucose monitoring and fitness tracking throughout the course of study. |
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| GLP-1 | Experimental | Adolescent patients being considered for GLP-1 receptor agonist therapy for obesity management will undergo continuous glucose monitoring and fitness tracking throughout the course of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Monitoring Program | Other | Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in BMI | assessment of change in BMI from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| Body Weight | Change in body weight (kg) | baseline through study completion, an average of 4 months |
| Fasting Glucose | change in fasting glucose levels from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| Fasting Insulin | change in fasting insulin levels from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| HbA1c | change in HbA1c levels from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| Lipid Panel | changes in lipid panel levels from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| Liver Enzymes | changes in liver enzymes from pre-intervention to post-intervention | baseline through study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Obesity-related Comorbidities | Defined as resolution or improvement according to prespecified clinical criteria | baseline through study completion, an average of 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl Sylvester, MD | Contact | 650-723-6439 | karls@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital - Stanford | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |