Effects of Gender-Affirming Hormone Therapy on Cardiovascular, Metabolic, and Mental Health Outcomes in Transgender Adults.

Starting soon

Conditions studied: Transgender Individuals

In brief

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.

Key facts

Study ID

NCT07394400

Run by

Milagros Rocha Barajas

People needed

94

Starts

2026-02-14

Expected to finish

2029-12-31

Last updated by the study team

2026-02-06

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Trans men and trans women over the age of 16

You may not qualify if…

• 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
• serious life-threatening diseases
• diseases that compromise follow-up
• BMI higher than 35

Where it is running

• Hospital Universitario Doctor Peset — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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