Status:
WITHDRAWN
Mechanisms of Blood Pressure Dysfunction in Transmen Receiving Testosterone
Lead Sponsor:
Yale University
Collaborating Sponsors:
The John B. Pierce Laboratory
Conditions:
Transgender Men
Blood Pressure
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this research is to explore the effects of chronic androgen exposure on sympathetic nervous system activity (SNSA) and baroreflex control of blood pressure responses in transgender men ...
Detailed Description
The purpose of this research is to study how testosterone affects blood pressure control in trans men. High testosterone levels are detrimental to the female cardiovascular system in that higher level...
Eligibility Criteria
Inclusion
- Both groups (trans men and cisgender women) must be healthy and non-smoking. Control participants must be cisgender women with regular menses every 26-34 days. Trans men participants must be currently receiving testosterone for gender affirming hormone therapy where physiologic doses of exogenous Dihydrotestosterone have been administered (via injection or transdermal application) for at least 3 months as prescribed by their local endocrine provider as part of their clinically indicated hormone therapy. Doses can vary depending on the size and goals of each patient, but blood testosterone will be between 400-1000 ng/dl.
Exclusion
- Subjects who smoke, have diabetes, or BP\>140/90 will be excluded.
- Subjects will not be taking medications during the study, including any insulin-sensitizing or cardiovascular medications.
- Subjects are excluded if they have lost \> 5 kg of weight within the past 6 months or perform high-intensity exercise \> 3 times/week.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04524325
Start Date
January 1 2023
End Date
June 30 2024
Last Update
November 3 2022
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