Effects of Estradiol on Cardiometabolic Health in Transgender Youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates how estradiol, with or without prior treatment using a gonadotropin releasing hormone analogue, impacts insulin sensitivity and vascular function in transgender females aged 13-16. The study compares these effects to those observed in cisgender controls of the same age group. By analyzing these health parameters, the research aims to provide insights into the cardiometabolic health of transitioning youth.

Why it matters

Who can join: the full rules

Inclusion Criteria (transgender females):

* Identify as a transgender female
* Age 13-16 years at the time of enrollment
* If on a gonadotropin releasing hormone analogue, \> 6 months exposure
* Plan to start estradiol clinically in \< 4 months

Inclusion Criteria (cisgender males and females):

* Males and females ages 13-16 years

Exclusion Criteria:

* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Antipsychotic medication use
* Type 1 or 2 diabetes (by medical history)
* Polycystic ovarian syndrome (PCOS for cisgender females)
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight\> 400 lbs
* On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
* Pregnancy (for cisgender females)

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Natalie Nokoff, MD, MSCS — University of Colorado, Denver
• Study coordinator: Natalie Nokoff, MD, MSCS
• Email: Natalie.Nokoff@childrenscolorado.org
• Phone: 720-777-3607

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.