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临床试验/NCT05046379
NCT05046379已完成不适用

Lipidomics for Identification of New Biomarkers for Fabry Disease

Vastra Gotaland Region3 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
3
主要终点
Lipidomics

研究概览

简要总结

Compare levels of lipids between well characterised enzymatically-genetically-phenotypically patients with Fabry disease and healthy controls (with no Fabry disease).

Correlate levels of lipids in patients with Fabry disease to clinical outcomes/manifestations of the disease.

详细描述

The hypothesis is that Sphingosine-1 Phosphate (S1P) or any other related sphingoid bases and/or other lipid class could be a marker of the severity of cardiovascular remodelling in Fabry disease.

The overall approach is, by minimising possible pre-analytical and analytical biases, to study by lipidomics in well characterised enzymatically, genetically and phenotypically patients with Fabry disease, if S1P or any other lipid (including other glycosphingolipids) is shown to be a biomarker for the diagnosis, monitoring of disease activity and prognosis (including cardiovascular outcomes).

研究设计

研究类型
Observational
观察模型
Other
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

Lipidomics

时间窗: Samples are going be collected during 1 year at the fasting state in the morning. At a random day in both Fabry patients with no treatment and cases. Up to 24 hours before next treatment in Fabry patients with ongoing treatment.

Lipid species from several lipid classes

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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