[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07316816":3,"trial-entities:NCT07316816":114,"trial-summary:NCT07316816":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":10,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":59,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":13,"eligibility_criteria":66,"std_ages":79,"locations":82,"central_contacts":108,"overall_officials":111,"references":112,"see_also_links":113},"NCT07316816","81022","Stanford Pediatric Healthy Weight Index","RECRUITING","2030-12","2025-12","2026-01-05","Stanford University","OTHER",false,"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.","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.",[17],"Obesity & Overweight",[19,20,21,22,23],"Metabolism","Continuous Glucose Monitoring","Obesity","Bariatric Surgery","GLP-1","INTERVENTIONAL","DIAGNOSTIC",[27],"NA",{"count":29,"type":30},120,"ESTIMATED",[32],{"type":12,"name":33,"description":34,"armGroupLabels":35},"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.",[22,23],[37,41,44,47,50,53,56],{"measure":38,"description":39,"timeFrame":40},"Percent Reduction in BMI","assessment of change in BMI from pre-intervention to post-intervention","baseline through study completion, an average of 4 months",{"measure":42,"description":43,"timeFrame":40},"Body Weight","Change in body weight (kg)",{"measure":45,"description":46,"timeFrame":40},"Fasting Glucose","change in fasting glucose levels from pre-intervention to post-intervention",{"measure":48,"description":49,"timeFrame":40},"Fasting Insulin","change in fasting insulin levels from pre-intervention to post-intervention",{"measure":51,"description":52,"timeFrame":40},"HbA1c","change in HbA1c levels from pre-intervention to post-intervention",{"measure":54,"description":55,"timeFrame":40},"Lipid Panel","changes in lipid panel levels from pre-intervention to post-intervention",{"measure":57,"description":58,"timeFrame":40},"Liver Enzymes","changes in liver enzymes from pre-intervention to post-intervention",[60],{"measure":61,"description":62,"timeFrame":40},"Obesity-related Comorbidities","Defined as resolution or improvement according to prespecified clinical criteria","ALL","10 Years","18 Years",{"inclusion":67,"exclusion":71,"raw_text":78},[68,69,70],"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.",[72,73,74,75,76,77],"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","Inclusion Criteria:\n\n* Class 2 and 3 obesity\n* Patient in the Adolescent Bariatric Program at Stanford Children's that is eligible for either laparoscopic sleeve gastrectomy or GLP1 Receptor Agonist Therapy\n* Willingness to wear a CGM and physiological monitor for the duration of the study.\n\nExclusion Criteria:\n\n* Hypothalamic and syndromic obesity\n* BMI \\> 55\n* Plan to undergo bariatric surgical procedure other than sleeve gastrectomy\n* Prior bariatric surgical procedure\n* Active GLP treatment (within past 3 months)\n* Unable to read, understand, or complete the informed consent in English or Spanish",[80,81],"CHILD","ADULT",[83],{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":105},"Lucile Packard Children's Hospital - Stanford","Palo Alto","California","94304","United States",[90,95,99,102],{"name":91,"role":92,"phone":93,"email":94},"Elton Ortiz, MS","CONTACT","650-723-6439","elton@stanford.edu",{"name":96,"role":92,"phone":97,"email":98},"Elena Harnish, MA","650-739-6427","eharnish@stanford.edu",{"name":100,"role":101},"Karl Sylvester, MD","PRINCIPAL_INVESTIGATOR",{"name":103,"role":104},"Gillian Fell, MD, PhD","SUB_INVESTIGATOR",{"lat":106,"lon":107},37.44188,-122.14302,[109],{"name":100,"role":92,"phone":93,"email":110},"karls@stanford.edu",[],[],[],{"nct_id":4,"conditions":115,"biomarkers":116},[21],[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study with a planned enrollment of 120 participants. It is a prospective cohort study, meaning participants are followed over time.","completed","Stanford Pediatric Healthy Weight Index for Obesity & Overweight","This study is developing a simple way to measure how well the body uses insulin and overall heart and metabolic health in children and teenagers with obesity. It uses a Remote Monitoring Program where participants wear continuous glucose monitors and fitness trackers. Researchers will collect data from these devices, along with lab tests, to understand how activity and glucose levels relate to metabolic problems. You may be able to join if you are 10 to 18 years old, have Class 2 or 3 obesity, and are already in the Adolescent Bariatric Program at Stanford Children's, eligible for either bariatric surgery or GLP1 Receptor Agonist Therapy. The study aims to see how much body mass index (BMI), body weight, and fasting glucose levels change over about 4 months. The current recruitment status is unclear.","Primary endpoints are measured from baseline through study completion, which is an average of 4 months.",133,"You would wear a continuous glucose monitor and a wearable fitness device for the duration of the study. Monitoring will occur at three time points: before treatment, during early treatment, and 3 months after treatment or dose stabilization.","Not stated in the trial record.",[33],"v2"]