[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04596592":3,"trial-entities:NCT04596592":95,"trial-summary:NCT04596592":98},{"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":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":34,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":16,"eligibility_criteria":51,"std_ages":68,"locations":70,"central_contacts":86,"overall_officials":90,"references":93,"see_also_links":94},"NCT04596592","19-1226","Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth","RECRUITING","2026-07-31","2025-06","2025-06-10","2021-02-15","University of Colorado, Denver","OTHER",false,"To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.",null,[18,19,20],"Transgenderism","Gender Dysphoria","Insulin Sensitivity",[],"OBSERVATIONAL",[],{"count":25,"type":26},90,"ESTIMATED",[],[29,32],{"measure":30,"timeFrame":31},"Insulin sensitivity","Change from baseline to 12 months",{"measure":33,"timeFrame":31},"Brachial artery flow mediated dilation",[35,38,41,43,46],{"measure":36,"description":37,"timeFrame":31},"Large artery stiffness","Carotid artery ultrasound",{"measure":39,"description":40,"timeFrame":31},"Cerebrovascular function","Middle cerebral artery blood flow",{"measure":42,"timeFrame":31},"VO2 peak",{"measure":44,"description":45,"timeFrame":31},"Fat mass","DXA",{"measure":47,"description":45,"timeFrame":31},"Fat-free mass","ALL","13 Years","16 Years",{"inclusion":52,"exclusion":58,"raw_text":67},[53,54,55,56,57],"Identify as a transgender female","Age 13-16 years at the time of enrollment","If on a gonadotropin releasing hormone analogue, \\> 6 months exposure","Plan to start estradiol clinically in \\\u003C 4 months","Males and females ages 13-16 years",[59,60,61,62,63,64,65,66],"Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures","Antipsychotic medication use","Type 1 or 2 diabetes (by medical history)","Polycystic ovarian syndrome (PCOS for cisgender females)","Hypertension (resting BP ≥ 140\u002F90 mm\u002FHg)","Weight\\> 400 lbs","On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)","Pregnancy (for cisgender females)","Inclusion Criteria (transgender females):\n\n* Identify as a transgender female\n* Age 13-16 years at the time of enrollment\n* If on a gonadotropin releasing hormone analogue, \\> 6 months exposure\n* Plan to start estradiol clinically in \\\u003C 4 months\n\nInclusion Criteria (cisgender males and females):\n\n* Males and females ages 13-16 years\n\nExclusion Criteria:\n\n* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures\n* Antipsychotic medication use\n* Type 1 or 2 diabetes (by medical history)\n* Polycystic ovarian syndrome (PCOS for cisgender females)\n* Hypertension (resting BP ≥ 140\u002F90 mm\u002FHg)\n* Weight\\> 400 lbs\n* On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)\n* Pregnancy (for cisgender females)",[69],"CHILD",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Natalie Nokoff, MD","CONTACT","720-777-3607","natalie.nokoff@childrenscolorado.org",{"lat":84,"lon":85},39.72943,-104.83192,[87],{"name":88,"role":80,"phone":81,"email":89},"Natalie Nokoff, MD, MSCS","Natalie.Nokoff@childrenscolorado.org",[91],{"name":88,"affiliation":12,"role":92},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":109},true,{"design":101,"status":102,"heading":6,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an observational study planning to enroll 90 participants aged 13-16 years. It compares transgender females to cisgender males and females.","completed","This observational study is looking at how estradiol, a hormone used in gender transition, affects the heart and metabolism in transgender females. Researchers want to understand how estradiol, with or without prior use of a puberty blocker (gonadotropin releasing hormone analogue), impacts insulin sensitivity (how well your body uses sugar) and vascular function (how well your blood vessels work). You might be able to join if you are a transgender female aged 13-16 who plans to start estradiol soon, or if you are a cisgender male or female aged 13-16. The study aims to see changes in insulin sensitivity and blood vessel function over 12 months. The current status of this study is unclear.","Participants will be followed for changes in insulin sensitivity and blood vessel function for 12 months.",114,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]