Cardiovascular diseases
Conditions
Interventions
This is an observational study. One hundred and fifty transgender men, 18 to 59 years old, without previous gender affirming hormone therapy (GAHT) or having stopped GAHT at least six months before th
Sponsors
Universidade Federal de São Paulo - Escola Paulista de Medicina
Centro de Referência e Treinamento DST/AIDS-SP
Eligibility
Sex/Gender
Male
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Transgender men; 18 to 59 years old; no previous hormone therapy; or hormone therapy stopped at least 6 months before the begining of the study; willing to start testosterone therapy
Exclusion criteria
Exclusion criteria: Not being able to understand the protocol rules; not being able to attend the institution for the scheduled visits and laboratory exams
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the endothelial function changes related to testosterone use in transgender men, using a peripheral arterial tonometry device, Endopat. We aim to detect a statistically significant decrease of the reactive hyperemia index after testosterone use. Data will be collected before and after 12 and 18 months of testosterone use, with paired t test or Wilcoxon for statistical analysis.;To evaluate the blood pressure changes related to testosterone use in transgender men, using a 24 hour ambulatory blood pressure monitor. We aim to detect a statistically significant increase in systolic blood pressure after testosterone use. Data will be collected before and after 6, 12 and 18 months of testosterone use, with paired t test or Wilcoxon for statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the body composition changes related to testosterone use in transgender men, using dual energy x ray absorptiometry (DXA). We aim to detect a statistically significant increase in lean mass, as well as a decrease in fat mass after testosterone use. Data will be collected before and after 12 and 18 months of testosterone use, with paired t test or Wilcoxon for statistical analysis.;To evaluate the plasma level changes in lipid levels, inflammatory markers (C reactive protein, ferritin, alpha tumoral necrosis factor, interleukin 6) and endothelial function markers (asymmetric dimethylarginine, ADMA) related to by testosterone use in transgender men, using enzymatic, chemiluminescence and high performance liquid chromatography (HPLC) methods. We aim to detect a statistically significant decrease in HDL cholesterol, as well as an increase in triglycerides, inflammatory markers and ADMA after testosterone use. Data will be collected before and after 6, 12 and 18 months of testosterone use, with paired t test or Wilcoxon for statistical analysis. | — |
Countries
Brazil
Contacts
Public ContactMagnus Regios da Silva
Escola Paulista de Medicina/Universidade Federal de São Paulo
Outcome results
None listed