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临床试验/NCT04085094
NCT04085094已完成不适用

Gender Differences in Renal Disease Progression: an Analysis of Potential Mechanisms Using Modern Radiological Techniques

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Change in renal microperfusion according to dietary salt intake in healthy and CKD

研究概览

简要总结

The purpose of the GenderBOLD study is to shed light on the mechanisms responsible for women's lower susceptibility to developing and progressing chronic renal disease, using modern imaging techniques, and applying different diets. The investigators postulate that oxygenation and renal perfusion are better conserved and change less in women than in men in different dietary situations (high salt-low salt), possibly because they are able to store excess salt in their skin and muscles. The investigators postulate that these differences are independent of their menstrual cycle. Finally, the investigators will analyze the renal functional reserve and changes in renal perfusion through an oral protein load and after sublingual nitroglycerin to assess whether potential différences exist between genders.

详细描述

Chronic kidney disease (CKD) affects about 10% of the adult population in Switzerland.

Despite decades of research, the mechanisms involved in the development and progression of CKD remain unclear, and there is a lack of preventative therapies. Women are relatively protected against CKD, but this topic has been little studied.

The kidney is very sensitive to hypoxia and its chronic oxygen depravation is the final step in the pathogenesis of CKD. A special MRI application, called BOLD-MRI, has the ability to measure renal tissue oxygenation in humans. In a recent BOLD-MRI study, the investigators demonstrated that cortical oxygenation is significantly higher in women than in men, which may explain women's lower susceptibility to declining renal function. However, whether this is true under different dietary conditions (high salt-low salt), and whether renal oxygenation changes throughout the menstrual cycle is unknown and will be assessed in this study.

Renal oxygenation depends on its perfusion. Renal micro-perfusion can be measured with contrast-enhanced ultrasound (CEUS) and is expressed as PI (perfusion index). CEUS is a recent imaging technique that combines conventional ultrasound with the administration of a microbubble contrast agent (a lipid or albumin-enveloped gas compound). The microbubbles are inert and eliminated by pulmonary and hepatic systems within one hour of administration. They are not nephrotoxic and have no major side effects. Whether there are differences in renal perfusion as measured with CEUS between men and women with and without CKD will be also assessed in this study.

Oxygenation of the kidneys does not only depend on their perfusion, but also on their consumption, mainly related to tubular active sodium transport. Thus, their oxygenation is lower in the case of a high salt diet compared to a low salt diet. This has been proven in men, but not in women.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in renal microperfusion according to dietary salt intake in healthy and CKD

时间窗: 1 month (5 days high salt- two weeks wash out- 5 days low salt)

Renal perfusion is measured with the contrast-enhanced ultrasound (CEUS)

Change in skin and muscle storage of sodium according to salt intake

时间窗: 1 month

Changes in cutaneous and muscle sodium storage measured by 23Na-MRI

Change in renal perfusion measured with CEUS after SL nitroglycerine

时间窗: before-5 minutes after NTG

Renal perfusion is measured with the contrast-enhanced ultrasound (CEUS)

Change in renal oxygenation after salty/unsalted diets in women compared to men

时间窗: 1 month

Renal oxygenation is measured by Blood Oxygen Level Dependent (BOLD-IRM)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregoire Wuerzner; MD

Principal Investigator

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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