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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04482920
Other study ID # 20-0572
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date August 31, 2023

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers
Gender All
Age group 17 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
p-aminohippurate clearance study
To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
Iohexol infusion
To measure glomerular filtration rate (GFR)

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in measured glomerular filtration rate (GFR) Baseline, 3 months
Secondary Change in effective renal plasma flow Baseline, 3 months
Secondary 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
Secondary Change in fat mass Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy Baseline, 3 months
Secondary Change in fat-free mass Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy Baseline, 3 months
Secondary Change in intracellular fluid Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy Baseline, 3 months
Secondary Change in extracellular fluid Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy Baseline, 3 months
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