Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT07316816

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Remote Monitoring Program

Study Details

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.

Conditions

Obesity & Overweight

Study ID

NCT07316816

Start date

Jan 5, 2026

Status verified date

Dec, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Bariatric Surgery

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.

experimental: GLP-1

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.

Interventions

Remote Monitoring Program

Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.

Primary outcome measure

  • Percent Reduction in BMI [ Time Frame: baseline through study completion, an average of 4 months ]
  • Body Weight [ Time Frame: baseline through study completion, an average of 4 months ]
  • Fasting Glucose [ Time Frame: baseline through study completion, an average of 4 months ]
  • Fasting Insulin [ Time Frame: baseline through study completion, an average of 4 months ]
  • HbA1c [ Time Frame: baseline through study completion, an average of 4 months ]
  • Lipid Panel [ Time Frame: baseline through study completion, an average of 4 months ]
  • Liver Enzymes [ Time Frame: baseline through study completion, an average of 4 months ]

Central Contacts and Locations

Central contacts

Karl Sylvester, MD

650-723-6439karls@stanford.edu

Locations

Lucile Packard Children's Hospital - Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Elton Ortiz, MS

650-723-6439elton@stanford.edu

Elena Harnish, MA

650-739-6427eharnish@stanford.edu

Principal Investigator:

Karl Sylvester, MD

More Information

Sponsor

Stanford University

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Keywords

  • Metabolism
  • Continuous Glucose Monitoring
  • Obesity
  • Bariatric Surgery
  • GLP-1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-01-05.