Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Lipocalin blood and urinary concentrations
研究概览
简要总结
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.
详细描述
This study is broken up into 5 groups:
The first is a pre-analytical study to determinate optimum conditions for lipocalin samples.
The second focuses on intra-individual variations of lipocalin levels in blood and urine.
The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study the role of renal function on serum and urines lipocalin levels.
Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary hyperaldosteronism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the group 1 and 2
- •Inclusion criteria:
- •Men having an age ranging between 18 and 35 years
- •Unhurt subject of any acute pathology for more than 7 days
- •Consent signed by the subject
排除标准
- •Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history
- •Subject presenting a known renal insufficiency
- •Subject presenting a known anaemia (Hb < 12g/dl)
- •Subject presenting a known diabetes
- •Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- •Subject presenting a chronic liver disease
- •Subject presenting a connectivite: Rhumatoid polyarthritis....
- •Crohns disease
- •Current tuberculosis
- •Any medicinal treatment
- •Subject participating in another protocol or in exclusion's period for another protocol
- •Absence of social insurance
- •For group 3
- •Inclusion criteria:
- •Men or women having an age ranging between 18 and 85 years
- •Unhurt subject of any acute pathology for more than 7 days
- •without any cardiovascular treatment
- •Consent signed by the subject
- •Exclusion criteria:
- •Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg or > 160/95 mmHg after 60 years)
- •Subject presenting a known renal insufficiency
- •Subject presenting a known diabetes
- •Woman who is pregnant
- •Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- •Subject presenting a chronic liver disease
- •Subject presenting a connectivite: Rhumatoid polyarthritis....
- •Crohns disease
- •Current tuberculosis
- •Subject presenting an effort angor or other coronaropathy
- •Subject with antecedant of endarterectomy of carotid
- •Subject with known abdominal aorta aneurism
- •Subject participating in another protocol or in exclusion's period for another protocol
- •Absence of social insurance
- •For group 4
- •Inclusion criteria:
- •Men or women having an age ranging between 18 and 85 years
- •Subject with chronique renal insufficiency
- •Consent signed by the subject
- •Exclusion criteria:
- •Subject presenting a known diabetes
- •Woman who is pregnant
- •Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- •Subject presenting a chronic liver disease
- •Subject presenting a connectivite: Rhumatoid polyarthritis....
- •Crohns disease
- •Current tuberculosis
- •Subject presenting an effort angor or other coronaropathy
- •Subject with antecedant of endarterectomy of carotid
- •Subject with known abdominal aorta aneurism
- •Subject participating in another protocol or in exclusion's period for another protocol
- 另有 18 项未显示
结局指标
主要结局
Lipocalin blood and urinary concentrations
时间窗: 8 months
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
次要结局
未报告次要终点