Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To find markers for a better definition of the meaning of microalbuminuria
研究概览
简要总结
Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and non-diabetic subjects.
However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no biomarkers that permit us to discriminate between these two conditions.
详细描述
A hypothesis free approach by using proteomic/metabolomic analyses in the urine samples of selected populations seems an appropriate approach by which to explore this issue. In addition, a driven hypothesis in the same groups of patients based on a sensitive marker of kidney injury also seems appropriate.
Urinary levels of KIM-1(Kidney Injury Molecule-1 ) have been found elevated in experimental diabetic nephropathy even before that MA . In addition, urinary levels of KIM-1 were found significantly elevated in type 1 diabetic patients with MA, in comparison with diabetics with normoalbuminuria and non-diabetic healthy controls. Moreover, low urinary KIM-1 levels at baseline were associated with the regression of MA during a follow-up of 2 years . Therefore, it could be hypothesized that the presence of MA + KIM-1 in urine samples would indicate renal injury rather than endothelial dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Adult patients with diabetes mellitus type 2 with microalbuminuria with and without retinopathy.
- •Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy
排除标准
- •Patients without microalbuminuria or patients with macroalbuminuria
结局指标
主要结局
To find markers for a better definition of the meaning of microalbuminuria
时间窗: 3 years
Improve diagnosis of diabetic nephropathy
Complementary markers for improving the performance of MA
时间窗: 3 years
Improve diagnosis of diabetic nephropathy
次要结局
- To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage(3 years)
- To test whether the enhancement of this specific marker of kidney injury is able to identify those patients in which MA really means diabetic nephropathy.(3 years)