protocolSection identificationModule nctId: NCT06291675, orgStudyIdInfo id: 2083/2022, briefTitle: Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2026-03-03, completionDateStruct date: 2033-03-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce.Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment.Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment.Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires.Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years.Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study., conditionsModule conditions: Gender Dysphoria, conditions: Hormone Therapy Induced Morphologic Change, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: gender-affirming hormone therapy, outcomesModule primaryOutcomes measure: Myocardial mass, primaryOutcomes measure: Cardiac function - LVEF, primaryOutcomes measure: cardiac function - cardiac output index, primaryOutcomes measure: Organ lipid content, primaryOutcomes measure: Subcutaneous to visceral fat ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chiari Stoffwechselambulanz, Medical University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Carola Deischinger, MD PhD, role: CONTACT, phone: +43140400, phoneExt: 20690, email: carola.deischinger@meduniwien.ac.at, contacts name: Alexandra Kautzky-Willer, Prof, MD, role: CONTACT, email: alexandra.kautzky-willer@meduniwien.ac.at, contacts name: Alexandra Kautzky-Willer, Prof, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Carola Deischinger, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False