Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Flow-mediated dilation of the branchial artery
研究概览
简要总结
The aim of the study is to assess if abnormal lipid levels in childhood could cause early damage of the inner layer of the vessels, the endothelium. Dysfunction of the endothelium is the first event in the development of atherosclerosis, is present at all stages of atherosclerosis and is potentially reversible in childhood. It has been suggested that dyslipidemia, via its detrimental effects on endothelium, could impair renal function. This study will assess the dysfunction of the kidneys in children with dyslipidemia.
详细描述
In children recruited in the study, family history of dyslipidemia or premature cardiovascular disease will be recorded. Furthermore, anthropometric and clinical characteristics will be noted and lipid measurements will be obtained at recruitment after a fasting period.
The investigators will test in children the flow-mediated dilation (FMD) which assesses the vasodilation due to the production of nitric oxide from the endothelium in response to occlusion-induced hyperaemia of the branchial artery and the carotid intima-media thickness (cIMT). These non-invasive ultrasound indices detect early vascular damage.
Renal function will be assessed in children with dyslipidemia by a new marker in serum, cystatin C, which is more accurate and reliable than creatinine. Also, creatinine serum levels and estimated glomerular filtration rate (eGFR) will be evaluated. Additionally, total protein, albumin, electrolyte and β2-microglobulin excretion in urine will be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents aged 7 to 17 years
- •Dyslipidemia (serum levels of LDL-cholesterol ≥95th percentile or serum levels of triglycerides ≥95th percentile or serum levels of HDL-cholesterol ≤5th percentile for age and sex)
排除标准
- •History of renal disease
- •Dyslipidemia caused by nephrotic syndrome or chronic kidney disease
- •Chronic use of medication
- •Acute or chronic inflammatory process
结局指标
主要结局
Flow-mediated dilation of the branchial artery
时间窗: At subject enrollment
Non-invasive ultrasound assessment of endothelial function.
Carotid intima-media thickness
时间窗: At subject enrollment
Non-invasive ultrasound assessment of early vascular disease.
Measurement of cystatin C in serum
时间窗: At subject enrollment
Cystatin C is a marker for assessing renal function
次要结局
- Assessment of eGFR(At subject enrollment)
- Number of participants with abnormal levels of lipoprotein a.(At subject enrollment)
- Levels of β2-microglobulin in urine(At subject enrollment)
- Serum creatinine levels(At subject enrollment)
研究者
Chrysoula Kosmeri
Principal Investigator
University of Ioannina