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Kidney FuNction in people receiving Gender affirming Hormone Therapy

Kidney FuNction in people receiving Gender affirming Hormone Therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23894
Enrollment
40
Registered
2021-06-11
Start date
2021-09-27
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Research in renal physiology

Interventions

None listed

Sponsors

Dr. D.H. van Raalte Department of Endocrinology, VUMC/AMC De Boelelaan 1117, 1081 HV, Amsterdam E-mail: d.vanraalte@amsterdamumc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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.

Contacts

Public ContactSarah van Eeghen

VUmc

s.a.vaneeghen@amsterdamumc.nl0645376907

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)