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NOT YET RECRUITING
NCT07542964

Transgender Analysis of Nephrological Studies Focused on Renal Metrics

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-09

Completion Date

2028-09

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

P-aminohippurate clearance study

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

DIAGNOSTIC_TEST

Iohexol infusion

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

DIAGNOSTIC_TEST

Hyperinsulinemic clamp

Glucose/insulin infusion to measure insulin sensitivity

Locations (1)

Amsterdam UMC, location VU medical centre, internal medicine

Amsterdam, North Holland, Netherlands