Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Insulin Sensitivity Clinical Trial

— PUBERTY  

Official title:

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596592
• Other study ID #: 19-1226
• Secondary ID: 1K23HL151868-01
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Natalie Nokoff, MD, MSCS
• Phone: 720-777-3607
• Email: Natalie.Nokoff[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gender Dysphoria
• Insulin Resistance
• Insulin Sensitivity
• Transgenderism

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		Change from baseline to 12 months
Primary	Brachial artery flow mediated dilation		Change from baseline to 12 months
Secondary	Large artery stiffness	Carotid artery ultrasound	Change from baseline to 12 months
Secondary	Cerebrovascular function	Middle cerebral artery blood flow	Change from baseline to 12 months
Secondary	VO2 peak		Change from baseline to 12 months
Secondary	Fat mass	DXA	Change from baseline to 12 months
Secondary	Fat-free mass	DXA	Change from baseline to 12 months