Kidney Diseases, Kidney Injury, Transgenderism
Conditions
Brief summary
The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.
Interventions
DIAGNOSTIC_TESTp-aminohippurate clearance study
To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
DIAGNOSTIC_TESTIohexol infusion
To measure glomerular filtration rate (GFR)
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to 30 Years
Inclusion criteria
* Identify as transgender * Age 17-30 years (inclusive) * Plan to start gender affirming hormone therapy (testosterone or estradiol) clinically in ≤ 1 months and remain on for at least 3 months
Exclusion criteria
* Cognitive, psychiatric or physical impairment resulting in inability to tolerate the study procedures (e.g. intellectual disability, schizophrenia, hallucinations) * Type 1 or Type 2 diabetes * Chronic kidney disease, or eGFR \<60ml/min/1.73m2 by CKD-EPI formulation * Uncontrolled hypertension (resting BP ≥ 140/90 mm/Hg) * Allergy to shellfish, iodine or iohexol * Currently taking: sulfonamides, procaine, thiazolesulfone and probenecid (renal clearance measurements of PAH cannot be made accurately if individuals are on these medications) * Prior gender affirming hormone therapy use * Prior gonadectomy * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in measured glomerular filtration rate (GFR) | Baseline, 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40]) | Baseline, 3 months | — |
| Change in fat mass | Baseline, 3 months | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy |
| Change in effective renal plasma flow | Baseline, 3 months | — |
| Change in intracellular fluid | Baseline, 3 months | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy |
| Change in extracellular fluid | Baseline, 3 months | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy |
| Change in fat-free mass | Baseline, 3 months | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy |
Countries
United States
Outcome results
None listed