NCT04482920已完成不适用
The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in measured glomerular filtration rate (GFR)
研究概览
简要总结
The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in measured glomerular filtration rate (GFR)
时间窗: Baseline, 3 months
次要结局
- 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)
- Change in intracellular fluid(Baseline, 3 months)
- Change in fat mass(Baseline, 3 months)
- Change in fat-free mass(Baseline, 3 months)
- Change in extracellular fluid(Baseline, 3 months)
研究者
研究点 (1)
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