Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Gender Dysphoria; Insulin Sensitivity; Transgenderism

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04596592

1K23HL151868-01 (U.S. NIH Grant/Contract)

19-1226

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

90 participants in 2 patient groups

Transgender

Cisgender