The objective of this observational study is to examine the impact of gender-affirming hormone therapy (GAHT) on mood in transgender individuals and to explore its potential association with early atherosclerotic processes. The main questions it aims to answer are:
* Whether GAHT in transgender individuals has a psychological and functional impact, assessed through mood, stress, and self-esteem. Additionally, the study will analyze whether morphofunctional changes (including body composition, muscle strength, cardiorespiratory fitness, and metabolic flexibility) are related to inflammatory responses and psychological well-being. * Whether the administration of GAHT poses a cardiovascular risk by influencing biochemical, inflammatory, and oxidative markers, mitochondrial function, and the activation of the NLRP3 inflammasome in leukocytes.
Participants will undergo evaluation of early stages of the atherosclerotic process through the analysis of leukocyte-endothelial interactions, adhesion molecule expression, and ankle-brachial index (ABI), as well as periodontal parameters. Overall, this study aims to contribute to improving healthcare delivery and promoting more equitable and gender-affirming medical services tailored to the needs of transgender individuals.
Trans men and trans women over the age of 16
systemic inflammatory diseases
uncontrolled infections
severe autoimmune diseases intersex biological conditions (resistance, severe sexual development or chromosomal abnormalities, congenital adrenal hyperplasia)
treatment with metformin, statins or oral contraceptives in the previous 6 months
Transgender individuals referred to a Gender Identity Unit who are requesting Gender Affirmation Hormone Therapy for the first time. It will consist of three visits: at the start, and after 6 and 12 months of treatment.
Cohort
Prospective
Not listed
Changes in the degree of activation of the inflammasome complex in transgender individuals following gender-affirming hormone therapy.
Relative protein expression of NLRP3, ASC, Caspase-1 and inflammatory mediators NFκB, JNK by Western Blot and normalized to the loading control protein in PBMC. This measurement will be taken at the start, and at 6 and 12 months of THAG.
Changes in endothelial function in the study population.
Evaluation of leucocytes adhesion to the endothelial cell in vitro by means of a parallel flow chamber system coupled to an inverted phase-contrast microscope. This measurement will be taken at the start, and at 6 and 12 months of THAG.
Changes in endothelial function at molecular level in the study population.
Evaluation of circulating levels of adhesion molecules - P-selectin, ICAM-1, and VCAM-1, levels of the pro-oxidant enzyme MPO and circulating cytokines (L1β, IL18, IL6, IL10 and TNFα) in serum using Luminex technique. This measurement will be taken at the start, and at 6 and 12 months of THAG.
Changes in the systemic inflammation status in the study population.
Evaluation of circulating levels of mtDNA in serum samples using RT-PCR. This measurement will be taken at the start, and at 6 and 12 months of THAG.
Evaluation of redox status (PBMCs and PMNs) in the study population.
Determination of redox status using flow cytometry with fluorescent probes. This measurement will be taken at the start, and at 6 and 12 months of THAG.
Evaluation of mitochondrial function of leukocytes (PBMCs and PMNs) in the study population.
Determination of mitochondrial function by analysing oxygen consumption in PBMCs using the Seahorse XF technique (Agilent). This measurement will be taken at the start, and at 6 and 12 months of THAG.
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Milagros Rocha Barajas
Lead sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor institution
Instituto de Salud Carlos III
Collaborator
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