[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399528":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":24,"responsibleParty":44,"collaborators":10,"id":46,"slug":10,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Transgender females",null,"Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months",{"label":13,"type":10,"description":14,"interventionNames":10},"Cisgender males","Cisgender male controls",[16],{"name":17,"affiliation":5,"role":18},"Natalie J Nokoff, MD, MSCS","PRINCIPAL_INVESTIGATOR",[20],{"name":17,"role":21,"phone":22,"phoneExt":10,"email":23},"CONTACT","720-777-6128","natalie.nokoff@childrenscolorado.org",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-104.83192,39.72943,{"lat":37,"lon":36},[40],{"name":41,"role":21,"phone":42,"phoneExt":10,"email":43},"Natalie Nokoff, MD, MSCS","720-777-3607","Natalie.Nokoff@childrenscolorado.org",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100399528",false,"NCT04482374","Puberty Suppression and Cardiometabolic Health","Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health","Inclusion Criteria:\n\n* Identify as a transgender female or cisgender male\n* Age 9-14 years at the time of enrollment\n* Tanner Stage 2-3 baseline pubertal development\n* Plan to start gonadotropin releasing hormone analogue clinically in \\\u003C 2 months (for transgender females only)\n\nExclusion Criteria:\n\n* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures\n* Type 1 or 2 diabetes (by medical history)\n* On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)\n* Hypertension (resting BP ≥ 140\u002F90 mm\u002FHg)\n* Weight \\> 400 lbs\n* On estrogen- or progesterone-containing medications at baseline\n* \\>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit","MALE","9 Years","14 Years",{"count":56,"type":57},30,"ESTIMATED","OBSERVATIONAL","This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.",[61,62,63,64],"Transgenderism","Insulin Sensitivity\u002FResistance","Endothelial Dysfunction","Vascular Stiffness","2025-06-05",{"date":67,"type":68},"2025-06-10","ACTUAL",{"date":70,"type":68},"2020-08-10",{"date":72,"type":57},"2026-07-31",{"name":5,"class":6},1]