Hormone Therapy
Conditions
Keywords
post menopausal hormone replacement therapy, transgender men, transgender women, nonbinary, cis gender, post menopause, HRT, hormone replacement therapy
Brief summary
1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. 2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
Detailed description
Participants are screened for eligibility. Study involves a 4.5 hour morning in the lab: 1. Participants come fasting 2. IV infusion and blood draws 3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks
Interventions
Captorpril challenge to each participant
DRUGIohexol
Iohexol infusion to evaluate measured GFR
Sponsors
University of Calgary
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 90 years * Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
Exclusion criteria
* Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening) * Cerebrovascular disease (transient ischemic attacks or stroke) * History of hypertension (BP\>140/90 or use of antihypertensive medications) * Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 * Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose \>7mmol/L) * Current smoker * Previous history of preeclampsia * Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First association in transgender women and cis women | 2025 | to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. |
| Second association in transgender men and cis men | 2025 | to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men. |
Countries
Canada
Contacts
Primary ContactDarlene Y Sola, BScN
Backup ContactVictoria Riehl-Tonn, BN
Outcome results
None listed