Recruiting NCT04596592
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transgenderism, Gender Dysphoria, Insulin Sensitivity. Basic parameters: 13 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.
Primary outcome measures
- Insulin sensitivity [Time frame: Change from baseline to 12 months]
- Brachial artery flow mediated dilation [Time frame: Change from baseline to 12 months]
Secondary outcome measures (5)
- Large artery stiffness [Time frame: Change from baseline to 12 months]
- Cerebrovascular function [Time frame: Change from baseline to 12 months]
- VO2 peak [Time frame: Change from baseline to 12 months]
- Fat mass [Time frame: Change from baseline to 12 months]
- Fat-free mass [Time frame: Change from baseline to 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT04596592 · 19-1226 · 1K23HL151868-01