Obesity & Overweight
Conditions
Keywords
Metabolism, Continuous Glucose Monitoring, Obesity, Bariatric Surgery, GLP-1
Brief summary
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.
Detailed description
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.
Interventions
Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Class 2 and 3 obesity * Patient in the Adolescent Bariatric Program at Stanford Children's that is eligible for either laparoscopic sleeve gastrectomy or GLP1 Receptor Agonist Therapy * Willingness to wear a CGM and physiological monitor for the duration of the study.
Exclusion criteria
* Hypothalamic and syndromic obesity * BMI \> 55 * Plan to undergo bariatric surgical procedure other than sleeve gastrectomy * Prior bariatric surgical procedure * Active GLP treatment (within past 3 months) * Unable to read, understand, or complete the informed consent in English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Enzymes | baseline through study completion, an average of 4 months | changes in liver enzymes from pre-intervention to post-intervention |
| Percent Reduction in BMI | baseline through study completion, an average of 4 months | assessment of change in BMI from pre-intervention to post-intervention |
| Body Weight | baseline through study completion, an average of 4 months | Change in body weight (kg) |
| Fasting Glucose | baseline through study completion, an average of 4 months | change in fasting glucose levels from pre-intervention to post-intervention |
| Fasting Insulin | baseline through study completion, an average of 4 months | change in fasting insulin levels from pre-intervention to post-intervention |
| HbA1c | baseline through study completion, an average of 4 months | change in HbA1c levels from pre-intervention to post-intervention |
| Lipid Panel | baseline through study completion, an average of 4 months | changes in lipid panel levels from pre-intervention to post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obesity-related Comorbidities | baseline through study completion, an average of 4 months | Defined as resolution or improvement according to prespecified clinical criteria |
Countries
United States
Contacts
Primary ContactKarl Sylvester, MD
Outcome results
None listed