The central objectives of this study are to comprehensively detail (intra)renal hemodynamic function and tubular function in transgender individuals before and after gender affirming hormone therapy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het betreft fysiologisch onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters/endpoints are the measurement of glomerular
filtration rate (GFR) and effective renal plasma flow (ERPF) as measured by
iohexol and p-amminohippurate (PAH) clearance.
Secondary outcome
Secondary endpoints are the estimation of intrarenal hemodynamic parameters
derived from Gomez equations, markers of tubular injury and changes in systemic
hemodynamic properties.
Background summary
Sex differences in renal physiology is a vastly understudied area, despite
known differences in sex-specific rates of chronic kidney disease. Renal
function decline is accelerated in men compared to women, suggesting a
potential harmful role for testosterone. Transgender individuals undergoing
hormone therapy provide a unique model to study the effects of gender affirming
hormone therapy on kidney function and renal physiology.
Study objective
The central objectives of this study are to comprehensively detail (intra)renal
hemodynamic function and tubular function in transgender individuals before and
after gender affirming hormone therapy.
Study design
Prospective observational study
Study burden and risks
The burden for participants consists of three study visits, two of which will
replace scheduled meetings that are a part of standard healthcare practice. In
total, participants will receive one venapuncture and four intravenous
cannulas, from which blood will be sampled (study total of 250mL) and iohexol +
p-amminohippurate will be administered to measure GFR and effective renal
plasma flow respectively. In addition, participants will be asked to collect a
24-hr urine sample on the day prior to the second and third study visit. During
the test visits, four additionally urine samples will be collected. Finally,
participants will be subjected to two different non-invasive measurement
techniques: finger-plethysmography (Nexfin®) and pulse-wave-analysis
(SphygmoCor®). The total risk of negative effects for participants in the
current study is considered low.
The transgender population is a unique population in which the effects of
exogenous cross-sex hormone administration can be studied. This study may
provide additional data on the safety of hormone therapy in this population and
may also lead to meaningful insights regarding the physiologic effects of sex
hormones on renal function in humans that may help to understand observations
from cohort studies which indicate differences in progression to end stage
kidney disease (ESKD) dependent on gender.
De boelelaan 1117
Amsterdam 1081HV
NL
De boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Transgender individuals starting gender affirming hormone therapy
18 years or older of age
Exclusion criteria
Iodine allergy
use of prescribed medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74561.029.20 |