Stanford Pediatric Healthy Weight Index

Stanford University

Status: Enrolling

Conditions: Obesity & Overweight

Treatments: Other: Remote Monitoring Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07316816

81022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Bariatric Surgery

Experimental group

Description:

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.

Treatment:

Other: Remote Monitoring Program

GLP-1

Experimental group

Description:

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.

Treatment:

Other: Remote Monitoring Program