Puberty Suppression and Cardiometabolic Health

Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04482374

Enrollment

Registered

2020-07-22

Start date

2020-08-10

Completion date

2026-07-31

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Insulin Sensitivity/Resistance, Transgenderism, Vascular Stiffness

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

9 Years to 14 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in insulin sensitivity	Baseline, 6 months	Insulin sensitivity assessed by the oral minimal model

Secondary

Measure	Time frame	Description
Change in body composition (fat mass, fat-free mass)	Baseline, 6 months	Body composition measured by DXA
Change in resting metabolic rate	Baseline, 6 months	Resting metabolic rate assessed by indirect calorimetry
Change in endothelial function	Baseline, 6 months	Endothelial function assessed by brachial artery flow mediated dilation
Change in large elastic artery stiffness	Baseline, 6 months	Large elastic assessed by carotid ultrasound
Change in cerebrovascular function	Baseline, 6 months	Middle cerebral artery blood flow assessed using bilateral transcranial Doppler

Countries

United States

Contacts

Primary ContactNatalie J Nokoff, MD, MSCS

natalie.nokoff@childrenscolorado.org720-777-6128

Outcome results