Vascular Effects of Sex Steroids in Transgender Adults (VESSEL)
Research type
Research Study
Full title
An Investigation into the Vascular Effects Gender-Affirming Hormone Therapy in Transgender People
IRAS ID
262489
Contact name
Christian Delles
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
The influence of exogenous and endogenous sex steroids upon vascular function and physiology is a topic of great interest. A deeper understanding of the alterations in vascular pathology and outcomes in transgender people receiving gender-affirming hormone therapy could be fundamental in informing the management of cardiovascular risk in this population and more broadly advance our understanding of the role of sex and gender in vascular health and disease.
The aim of this study is to recruit 50 transgender males and 50 transgender females who have received hormone therapy for more than 5 years and who are under the age of 50 and compare their cardiovascular risk to cisgender males and females. For the purposes of this study the term transgender encompasses all people whose gender identity differs in some way from the sex assigned to them at birth. Conversely, a cisgender person is a person who's sex assigned at birth is the same as their gender identity. Gender-affirming hormone therapy is hormone therapy (oestrogen or testosterone) aiming to align the characteristics of an individual with their gender identity.
To compare cardiovascular risk between these groups we will utilise a variety of validated techniques such as pulse wave analysis, studies of peripheral blood flow and endothelial function, capillaroscopy and carotid intima-media thickness. In addition we will assess serum biomarkers of insulin resistance, blood vessel function, inflammation and clotting. This study will increase our understanding of cardiovascular diseases in transgender people and will contribute to the implementation of better care and guidance in those receiving gender-affirming hormone therapies.
Summary of Results
This cohort study aimed to conduct vascular phenotyping procedures, including flow-mediated dilatation, peripheral artery tonometry, and pulse wave analysis (PWA) and velocity (PWV) in transgender individuals on long-term hormone therapy compared to cisgender individuals. Due to the impact of coronavirus disease 2019 (COVID-19), this study was discontinued prematurely, however, the feasibility of local recruitment of transgender participants through a variety of methods, and acceptability of the study protocol is demonstrated.
A total of 18 individuals, including 6 people who are transgender and 12 people who were cisgender were recruited to the study. This analysis demonstrated the feasibility of conducting a study within this cohort, as determined by predicted recruitment forecasts. In particular, there was successful recruitment of transgender populations via a variety of means, and broad acceptability of the study visit interventions. Although this preliminary descriptive analysis was underpowered to detect meaningful differences between groups, the group of transgender women demonstrated the most extreme values in almost all vascular measurements, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse pressure and PWV.
REC name
West of Scotland REC 4
REC reference
19/WS/0084
Date of REC Opinion
17 Jun 2019
REC opinion
Favourable Opinion