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临床试验/NCT00784030
NCT00784030已完成不适用

The Effect of Water Loading on Urinary Biomarkers

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Change in Urine cAMP Concentration and Urine Osmolality (UOsm)

研究概览

简要总结

Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
  • Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
  • Ages between 18 and 65
  • Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) > 60 ml/min/1.73 m2 with no history of kidney disease

排除标准

  • Women who are pregnant or nursing
  • Active dependency on drugs or alcohol
  • Diagnosis of syndrome of inappropriate antidiuresis
  • Currently taking a vasopressin agonist or antagonist
  • Blood sodium level less than < 135 mEq/L
  • For healthy participants, estimated glomerular filtration rate (level of kidney function) less than < 60 ml/min/1.73 m2

结局指标

主要结局

Change in Urine cAMP Concentration and Urine Osmolality (UOsm)

时间窗: pre- and post-water loading (2 hours)

Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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