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The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transgender males | Transgender males who are clinically ready to start testosterone |
| |
| Transgender females | Transgender females who are clinically ready to start estradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p-aminohippurate clearance study | Diagnostic Test | To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in measured glomerular filtration rate (GFR) | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in effective renal plasma flow | Baseline, 3 months | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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20 transgender youth and young adults (10 transgender females, 10 transgender males) before and 3 months after initiation of gender affirming hormone therapy to determine the impact of gender affirming hormone therapy on intrarenal hemodynamic function and tubular function.
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| Name | Affiliation | Role |
|---|---|---|
| Natalie J Nokoff, MD, MSCS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045' | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41858565 | Derived | van Eeghen SA, Suijk DLS, Pyle LL, Narongkiatikhun P, Choi YJ, Nokoff NJ, Bjornstad P, Heijer MD, van Raalte DH. Changes in uric acid metabolism and associated plasma proteomics during sex hormone therapy. J Clin Transl Endocrinol. 2026 Feb 27;44:100434. doi: 10.1016/j.jcte.2026.100434. eCollection 2026 May. | |
| 40193283 | Derived |
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| ID | Term |
|---|---|
| D014189 | Transsexualism |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D014570 | Urologic Diseases |
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Blood, urine
| Iohexol infusion | Diagnostic Test | To measure glomerular filtration rate (GFR) |
|
| Change in fat mass | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy | Baseline, 3 months |
| Change in fat-free mass | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy | Baseline, 3 months |
| Change in intracellular fluid | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy | Baseline, 3 months |
| Change in extracellular fluid | Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy | Baseline, 3 months |
| van Eeghen SA, Pyle L, Narongkiatikhun P, Choi YJ, Obeid W, Parikh CR, Vosters TG, van Valkengoed IG, Krebber MM, Touw DJ, den Heijer M, Bjornstad P, van Raalte DH, Nokoff NJ. Unveiling mechanisms underlying kidney function changes during sex hormone therapy. J Clin Invest. 2025 Mar 25;135(9):e190850. doi: 10.1172/JCI190850. eCollection 2025 May 1. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |