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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

This observational study is looking at how estradiol, a hormone used in gender transition, affects the heart and metabolism in transgender females. Researchers want to understand how estradiol, with or without prior use of a puberty blocker (gonadotropin releasing hormone analogue), impacts insulin sensitivity (how well your body uses sugar) and vascular function (how well your blood vessels work). You might be able to join if you are a transgender female aged 13-16 who plans to start estradiol soon, or if you are a cisgender male or female aged 13-16. The study aims to see changes in insulin sensitivity and blood vessel function over 12 months. The current status of this study is unclear.

Study design
This is an observational study planning to enroll 90 participants aged 13-16 years. It compares transgender females to cisgender males and females.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in insulin sensitivity and blood vessel function for 12 months.

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NCT04596592

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Recruiting
Not specifiedAges 13–16Observational
University of Colorado, Denver
~90 participants
Updated 2025-06-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin sensitivity
Measured over Change from baseline to 12 months
+1 more outcome measured

Conditions

Transgenderism
Gender Dysphoria
Insulin Sensitivity

Explore related trials

Gender Dysphoria

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Natalie Nokoff, MD, MSCS · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Natalie Nokoff, MD, MSCS
[email protected]
720-777-3607
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Males and females ages 13-16 years

Exclusion

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)

What this trial measures

  • Insulin sensitivityChange from baseline to 12 months
  • Brachial artery flow mediated dilationChange from baseline to 12 months