Effects of Estradiol on Cardiometabolic Health in Transgender Youth
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
This study tests how estradiol affects insulin sensitivity and blood vessel health in transgender girls aged 13-16 compared to girls who are not transgender.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 13 Years to 16 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04596592 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates how estradiol, with or without prior treatment using a gonadotropin releasing hormone analogue, impacts insulin sensitivity and vascular function in transgender females aged 13-16. The study compares these effects to those observed in cisgender controls of the same age group. By analyzing these health parameters, the research aims to provide insights into the cardiometabolic health of transitioning youth.
Who should consider this trial
Good fit: Ideal candidates include transgender females aged 13-16 who are planning to start estradiol therapy within four months and have been on a gonadotropin releasing hormone analogue for over six months.
Not a fit: Patients with cognitive, psychiatric, or physical impairments, or those with certain medical conditions such as diabetes or hypertension, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of the cardiometabolic health risks and benefits associated with hormone therapy in transgender youth.
How similar studies have performed: While there is ongoing research in this area, this specific approach to evaluating cardiometabolic health in transitioning youth is relatively novel.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Nokoff, MD, MSCS — University of Colorado, Denver
- Study coordinator: Natalie Nokoff, MD, MSCS
- Email: Natalie.Nokoff@childrenscolorado.org
- Phone: 720-777-3607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.