Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-16
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Transgender and cisgender adolescents
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Transgender
Group B: Cisgender
Trial outcomes
Primary outcomes
1
Insulin sensitivity
Time frame
Change from baseline to 12 months2
Brachial artery flow mediated dilation
Time frame
Change from baseline to 12 monthsSecondary outcomes
1
Large artery stiffness
Carotid artery ultrasound
Time frame
Change from baseline to 12 months2
Cerebrovascular function
Middle cerebral artery blood flow
Time frame
Change from baseline to 12 months3
VO2 peak
Time frame
Change from baseline to 12 months4
Fat mass
DXA
Time frame
Change from baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov