Puberty Suppression and Cardiometabolic Health

Launched by UNIVERSITY OF COLORADO, DENVER · Jul 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how puberty suppression affects health in transgender females, specifically looking at their insulin sensitivity (how well their body uses sugar), metabolic rate (how quickly they burn energy), and blood vessel health. The researchers will compare the results from transgender females who are starting treatment with a specific medication (gonadotropin releasing hormone agonist) to similar cisgender males (those who identify with the sex they were assigned at birth) over a period of six months.

To participate in this study, individuals must be between the ages of 9 and 14 and identify as either a transgender female or a cisgender male. They should also be in the early stages of puberty (Tanner Stage 2-3) and planning to start the hormone treatment soon. Participants will be closely monitored during the study to see how their health changes with treatment. It's important to note that certain health conditions or medications may prevent someone from joining the trial, so eligibility will be carefully assessed. This study aims to provide valuable insights into the effects of puberty suppression on the health of transgender youth.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Identify as a transgender female or cisgender male
• • Age 9-14 years at the time of enrollment
• • Tanner Stage 2-3 baseline pubertal development
• • Plan to start gonadotropin releasing hormone analogue clinically in \< 2 months (for transgender females only)
• Exclusion Criteria:
• • Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
• • Type 1 or 2 diabetes (by medical history)
• • On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
• • Hypertension (resting BP ≥ 140/90 mm/Hg)
• • Weight \> 400 lbs
• • On estrogen- or progesterone-containing medications at baseline
• • \>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit