NCT Number: NCT07316816
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.
Interested in participating?
Request Info10 year–18 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
Location status: Recruiting
Elena Harnish, MA
CONTACT
Elton Ortiz, MS
CONTACT
Gillian Fell, MD, PhD
SUB_INVESTIGATOR
Karl Sylvester, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.
Time frame: baseline through study completion, an average of 4 months
assessment of change in BMI from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Change in body weight (kg)
Time frame: baseline through study completion, an average of 4 months
change in fasting glucose levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
change in fasting insulin levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
change in HbA1c levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
changes in lipid panel levels from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
changes in liver enzymes from pre-intervention to post-intervention
Time frame: baseline through study completion, an average of 4 months
Defined as resolution or improvement according to prespecified clinical criteria
Contact information is provided by the study sponsor or research team.
Stanford University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738029
Body Weight, Nutrition Disorders
Tampere, Pirkanmaa, Finland
View Trial DetailsNCT07728383
Body Weight, Nutrition Disorders
Minneapolis, Minnesota, United States
View Trial DetailsNCT07317310
Behavior, Body Weight
Taipei, Taiwan
View Trial DetailsNCT07724522
Body Weight, Cardiovascular Diseases
Washington D.C., District of Columbia, United States
View Trial Details