Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT04596592
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014189', 'term': 'Transsexualism'}, {'id': 'D000068116', 'term': 'Gender Dysphoria'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Optional consent for DNA collection and storage'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'Change from baseline to 12 months'}, {'measure': 'Brachial artery flow mediated dilation', 'timeFrame': 'Change from baseline to 12 months'}], 'secondaryOutcomes': [{'measure': 'Large artery stiffness', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Carotid artery ultrasound'}, {'measure': 'Cerebrovascular function', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Middle cerebral artery blood flow'}, {'measure': 'VO2 peak', 'timeFrame': 'Change from baseline to 12 months'}, {'measure': 'Fat mass', 'timeFrame': 'Change from baseline to 12 months', 'description': 'DXA'}, {'measure': 'Fat-free mass', 'timeFrame': 'Change from baseline to 12 months', 'description': 'DXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgenderism', 'Gender Dysphoria', 'Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transgender and cisgender adolescents', 'eligibilityCriteria': '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 \\< 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 ≥ 140/90 mm/Hg)\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)'}, 'identificationModule': {'nctId': 'NCT04596592', 'acronym': 'PUBERTY', 'briefTitle': 'Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth', 'orgStudyIdInfo': {'id': '19-1226'}, 'secondaryIdInfos': [{'id': '1K23HL151868-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL151868-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transgender'}, {'label': 'Cisgender'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalie Nokoff, MD', 'role': 'CONTACT', 'email': 'natalie.nokoff@childrenscolorado.org', 'phone': '720-777-3607'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Natalie Nokoff, MD, MSCS', 'role': 'CONTACT', 'email': 'Natalie.Nokoff@childrenscolorado.org', 'phone': '720-777-3607'}], 'overallOfficials': [{'name': 'Natalie Nokoff, MD, MSCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}