NCT07316816

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Dec 2030

First Submitted

Initial submission to the registry

December 8, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

December 8, 2025

Last Update Submit

December 18, 2025

Conditions

Obesity & Overweight

Keywords

MetabolismContinuous Glucose MonitoringObesityBariatric SurgeryGLP-1

Outcome Measures

Primary Outcomes (7)

  • 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

Secondary Outcomes (1)

  • Obesity-related Comorbidities

    baseline through study completion, an average of 4 months

Study Arms (2)

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.

Other: Remote Monitoring Program

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.

Other: Remote Monitoring Program

Interventions

Remote Monitoring ProgramOTHER

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

Bariatric SurgeryGLP-1

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Karl Sylvester, MD

CONTACT

650-723-6439karls@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 5, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)