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NOT YET RECRUITING
NCT07394400

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

Sponsor: Milagros Rocha Barajas

View on ClinicalTrials.gov

Summary

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.

Official title: A Comprehensive Assessment of the Impact of Gender-Affirming Hormone Therapy on Cardiovascular Risk, Metabolic Health, and Mood Disorders in Transgender Individuals.

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

94

Start Date

2026-02-14

Completion Date

2029-12-31

Last Updated

2026-02-06

Healthy Volunteers

Yes

Locations (1)

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain