Transgender Analysis of Nephrological Studies Focused on Renal Metrics

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorAmsterdam UMC, location VUmc

About this trial

This study investigates how sex hormones affect kidney function in people undergoing gender-affirming hormone therapy (GAHT). We know men have a faster progression of kidney disease. Earlier studies suggest that the female sex hormone estradiol may have a protective effect on kidney function while the male sex hormone testosterone may have the opposite effect. But the reasons why this happens remain unclear. By studying participants undergoing (GAHT) we gain insight into the mechanisms by which testosterone and estradiol influence the kidneys. People undergoing GAHT provide a unique chance to study how sex hormones interact with the kidneys. The results may help us to understand why men and women exhibit differences in kidney disease development. This study will include 30 men and 30 women, aged 18 to 40, who start GAHT. Participants will have three study visits, two of which will happen during their scheduled healthcare appointments. During the first visit, a screening will take place to check if patients can take part in the study. At study visits before and after one year of therapy, kidney function is measured, kidney MRI is performed, urine is collected and a small sample of fat tissue. Taking part in the study does not delay the start of GAHT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with gender dysphoria according to DSM-V

Expected to start gender-affirming hormone treatment in the upcoming month

Disqualifiers

Current or prior use of gender-affirming hormone therapy

Participation in other studies

Concomitant use of medication (specifically: antihypertensive agents, products, antidepressants, antipsychotic agents)

Known kidney disease (eGFR < 60 ml/min; UACR > 2.5 mg/mmol)

Trial population

The source population consists of adult patients with gender dysphoria, who are scheduled to start with GAHT in the Amsterdam University Medical Centre (AUMC) in Amsterdam. A total of 60 transgender individuals (30 transgender women, 30 transgender men) will be selected from this outpatient clinic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • P-aminohippurate clearance study

    Diagnostic test

    To measure effective renal plasma flow (ERPF), small doses of a substance called p-aminohippurate will be used

  • Iohexol infusion

    Diagnostic test

    To measure glomerular filtration rate (GFR) iohexol clearance will be performed

  • Hyperinsulinemic clamp

    Diagnostic test

    Glucose/insulin infusion to measure insulin sensitivity

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Transgender males3 interventions
Group B: Transgender women3 interventions

Trial outcomes

Primary outcomes

1

Change in measured glomerular filtration rate (GFR)

Time frame
Baseline, 12 months after start GAHT

Secondary outcomes

1

Change in effective renal plasma flow (ERPF)

Time frame
Baseline, 12 months after start GAHT
2

Change in systemic hemodynamic function

Time frame
Baseline, 12 months after start GAHT
3

Change in insulin sensitivity

Time frame
Baseline, 12 months after start GAHT
4

Change in markers of tubular physiology

Time frame
Baseline, 12 months after start GAHT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

Dutch Kidney Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: