Effects of Pubertal Blockade and Estradiol on Cardiometabolic Health in Transgender and Cisgender Youth Ages 13 to 16

What this Trial Is About

Researchers are studying how estradiol treatment, with or without prior use of a gonadotropin releasing hormone analogue, affects insulin sensitivity and vascular function in transgender females compared to cisgender males and females aged 13 to 16 years. The study aims to understand changes in cardiometabolic health during puberty and early hormone therapy in these youth. This observational study is sponsored by the University of Colorado, Denver, and focuses on transgenderism, gender dysphoria, and insulin sensitivity. Participants include transgender females who identify as such, are between 13 and 16 years old, and either have been on gonadotropin releasing hormone analogues for more than 6 months or plan to start estradiol within 4 months. Cisgender males and females aged 13 to 16 years also participate as control groups. The study observes these groups without assigning specific treatments, tracking natural changes over a 12-month period. During the study, researchers measure insulin sensitivity and brachial artery flow mediated dilation at the start and after 12 months. Other assessments include large artery stiffness, cerebrovascular function, VO2 peak a measure of aerobic fitness, fat mass, and fat-free mass. Participants undergo evaluations to monitor cardiometabolic health changes, with safety and procedure tolerance also observed. The total study duration for each participant is 12 months.

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth