Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
Recruiting
- Conditions
- TransgenderismGender DysphoriaInsulin Sensitivity
- Registration Number
- NCT04596592
- Lead Sponsor
- University of Colorado, Denver
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Read More
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)
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brachial artery flow mediated dilation Change from baseline to 12 months Insulin sensitivity Change from baseline to 12 months
- Secondary Outcome Measures
Name Time Method Cerebrovascular function Change from baseline to 12 months Middle cerebral artery blood flow
VO2 peak Change from baseline to 12 months Fat-free mass Change from baseline to 12 months DXA
Fat mass Change from baseline to 12 months DXA
Large artery stiffness Change from baseline to 12 months Carotid artery ultrasound
Trial Locations
- Locations (1)
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States