Puberty Suppression and Cardiometabolic Health

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Endothelial Dysfunction

Vascular Stiffness

Insulin Sensitivity/Resistance

Transgenderism

Study type

Observational

Funder types

Other

Identifiers

NCT04482374

19-2109

Details and patient eligibility

About

This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.

Enrollment

30 estimated patients

Sex

Male

Ages

9 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Identify as a transgender female or cisgender male
Age 9-14 years at the time of enrollment
Tanner Stage 2-3 baseline pubertal development
Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only)

Exclusion criteria

Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
Type 1 or 2 diabetes (by medical history)
On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
Hypertension (resting BP ≥ 140/90 mm/Hg)
Weight > 400 lbs
On estrogen- or progesterone-containing medications at baseline
>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit