Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04237467
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D001070', 'term': 'Appetitive Behavior'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endothelial cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of endothelial function (flow-mediated dilation (FMD)', 'timeFrame': 'Baseline', 'description': 'Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of carotid artery compliance', 'timeFrame': 'Baseline', 'description': 'The carotid artery compliance index indicates how elastic the artery is. The index describes the change in arterial blood volume in response to a change in arterial blood pressure. Lower numbers are associated with worse outcomes (less elastic arteries).'}, {'measure': 'Evaluation of carotid artery beta stiffness index', 'timeFrame': 'Baseline', 'description': 'The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery)'}, {'measure': 'Carotid artery intimal-medial thickness', 'timeFrame': 'Baseline'}, {'measure': 'Evaluation of oxidant burden: oxidized LDL', 'timeFrame': 'Baseline', 'description': 'Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.'}, {'measure': 'Evaluation of oxidant burden: nitrotyrosine', 'timeFrame': 'Baseline', 'description': 'Nitrotyrosine measured in the blood and endothelial cells.'}, {'measure': 'Evaluation of vascular endothelial cell inflammation: NFkB', 'timeFrame': 'Baseline', 'description': 'Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.'}, {'measure': 'Evaluation of vascular endothelial cell inflammation: MCP-1', 'timeFrame': 'Baseline', 'description': 'Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.'}, {'measure': 'Evaluation of vascular endothelial cell inflammation: IL-6', 'timeFrame': 'Baseline', 'description': 'Interleukin 6 (IL-6) measured in blood and endothelial cells.'}, {'measure': 'Evaluation of vascular endothelial cell inflammation: CRP', 'timeFrame': 'Baseline', 'description': 'C-reactive protein (CRP) measured in blood and endothelial cells.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline'}, {'measure': 'Plasma lipid concentrations: total cholesterol', 'timeFrame': 'Baseline', 'description': 'Total cholesterol will be determined at baseline.'}, {'measure': 'Plasma lipid concentrations: triglycerides', 'timeFrame': 'Baseline', 'description': 'Triglycerides will be determined at baseline.'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'Baseline'}, {'measure': 'Whole body composition: Percent Lean Mass', 'timeFrame': 'Baseline', 'description': 'Percent lean mass will be determined using dual energy x-ray absorptiometry.'}, {'measure': 'Whole body composition: Percent Fat Mass', 'timeFrame': 'Baseline', 'description': 'Percent fat mass will be determined using dual energy x-ray absorptiometry.'}, {'measure': 'Regional body composition: Percent Lean Mass', 'timeFrame': 'Baseline', 'description': 'Regional percent lean mass will be determined using dual energy x-ray absorptiometry.'}, {'measure': 'Regional body composition: Percent Fat Mass', 'timeFrame': 'Baseline', 'description': 'Regional percent fat mass will be determined using dual energy x-ray absorptiometry.'}, {'measure': 'Body weight', 'timeFrame': 'Baseline'}, {'measure': 'Appetite ratings', 'timeFrame': 'Baseline'}, {'measure': 'Appetite-related peptides', 'timeFrame': 'Baseline'}, {'measure': 'D-Dimer', 'timeFrame': 'Baseline'}, {'measure': 'Alcohol use', 'timeFrame': 'Baseline'}, {'measure': 'Depression symptoms', 'timeFrame': 'Baseline'}, {'measure': 'Physical activity monitoring', 'timeFrame': '7 days', 'description': 'Physical activity will me monitored for 7 days with an ActivPALmonitor'}, {'measure': 'Energy intake', 'timeFrame': '3 days', 'description': 'Energy intake will be estimated with a 3-day food diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender', 'Gender Identity', 'Vascular Stiffness', 'Vascular Inflammation', 'Blood Pressure', 'Lipid Disorder', 'Appetitive Behavior']}, 'descriptionModule': {'briefSummary': 'This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and cisgender women and men.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transgender men from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.', 'genderDescription': 'Transgender men (people who were assigned female at birth but whose gender identity is male). They may or may not have legally changed their gender marker.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-40 years old or 50-75 years old\n* Identify as a transgender woman\n* Have taken testosterone for at least one year\n* Currently taking testosterone parenterally (injections) or transdermally (patches or gels)\n\nExclusion Criteria:\n\n* Don't identify as a transgender man\n* Not currently taking testosterone\n* Have been on testosterone for less than one year\n* History of hysterectomy/oophorectomy\n* Current tobacco smoker\n* Current illicit drug use\n* History of prior or active estrogen-dependent neoplasms\n* Acute liver or gallbladder disease\n* Venous thromboembolism\n* Hypertriglyceridemia \\>500 mg/dL\n* Fasted plasma glucose \\>7.0 mmol/L or previously treated diabetes\n* Resting blood pressure \\>140/90 mmHg"}, 'identificationModule': {'nctId': 'NCT04237467', 'briefTitle': 'Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults', 'orgStudyIdInfo': {'id': '19-2323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Older transgender men', 'description': 'This cohort will consist of transgender men aged 50-75 years old who have taken testosterone for at least one year.', 'interventionNames': ['Other: No intervention']}, {'label': 'Younger transgender men', 'description': 'This cohort will consist of transgender men aged 18-40 years old who have taken testosterone for at least one year.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There was no intervention.', 'armGroupLabels': ['Older transgender men', 'Younger transgender men']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Sean Iwamoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}