Kidney FuNction in people receiving Gender affirming Hormone Therapy
- Conditions
- Research in renal physiology
- Registration Number
- NL-OMON23894
- Lead Sponsor
- Dr. D.H. van Raalte Department of Endocrinology, VUMC/AMC De Boelelaan 1117, 1081 HV, Amsterdam E-mail: d.vanraalte@amsterdamumc.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Diagnosed with gender dysphoria according to DSM-V (transmen or transwomen)
-Age between 18 and 30 years
-Expected to start cross-sex hormone treatment in the upcoming month
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Current use of sex hormones
-Participation in other studies
-Concomitant use of medication (specifically: blood pressure lowering products, anti-depressants, anti-psychotic agents or medication prescribed for the treatment of attention deficit hyperactivity disorder),
-Known kidney disease (eGFR < 60 ml/min; UACR > 2,5 mg/mmol)
-Diabetes mellitus
-A history of cardiovascular disease (myocardial infarction; cardiac surgery or revascularization, unstable angina, heart failure, transient ischemic attack, cerebrovascular disease or a previously undiagnosed arrhythmia
-Known iodine related allergies
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Secondary endpoints are the estimation of intrarenal hemodynamic parameters derived from Gomez equations, markers of tubular injury and changes in systemic hemodynamic properties. Additionally, the M-value as a marker of insulin sensitivity will be determined using a hyperinsulinemic euglycemic clamp technique.