Actively Recruiting
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Led by University of Colorado, Denver · Updated on 2025-06-10
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how estradiol treatment, with or without prior use of a gonadotropin releasing hormone analogue, affects insulin sensitivity and vascular function in transgender females compared to cisgender males and females aged 13 to 16 years. The study aims to understand changes in cardiometabolic health during puberty and early hormone therapy in these youth. This observational study is sponsored by the University of Colorado, Denver, and focuses on transgenderism, gender dysphoria, and insulin sensitivity. Participants include transgender females who identify as such, are between 13 and 16 years old, and either have been on gonadotropin releasing hormone analogues for more than 6 months or plan to start estradiol within 4 months. Cisgender males and females aged 13 to 16 years also participate as control groups. The study observes these groups without assigning specific treatments, tracking natural changes over a 12-month period. During the study, researchers measure insulin sensitivity and brachial artery flow mediated dilation at the start and after 12 months. Other assessments include large artery stiffness, cerebrovascular function, VO2 peak (a measure of aerobic fitness), fat mass, and fat-free mass. Participants undergo evaluations to monitor cardiometabolic health changes, with safety and procedure tolerance also observed. The total study duration for each participant is 12 months.
CONDITIONS
Brief Title
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Identify as a transgender female aged 13 to 16 years at enrollment
- If using a gonadotropin releasing hormone analogue, have more than 6 months of exposure
- Plan to start estradiol treatment within 4 months
- Cisgender males and females aged 13 to 16 years
You will not qualify if you...
- Cognitive, psychiatric, or physical impairments that prevent tolerating study procedures
- Use of antipsychotic medications
- History of type 1 or type 2 diabetes
- Polycystic ovarian syndrome in cisgender females
- Hypertension with resting blood pressure of 140/90 mm/Hg or higher
- Weight over 400 pounds
- Use of oral progesterone medications, including combined oral contraceptives or etonogestrel implant
- Pregnancy in cisgender females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants are observed to assess cardiometabolic health changes over time.
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
N
Natalie Nokoff, MD, MSCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here