The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia

Conditions
-----------------
Dyslipidemias, Children, Only, Endothelial Dysfunction, Renal Dysfunction, Hypercholesteremia in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: History of renal disease Dyslipidemia caused by nephrotic syndrome or chronic kidney disease Chronic use of medication Acute or chronic inflammatory process

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dyslipidemia group<br>Children and adolescents with dyslipidemia | |
| Control group<br>Children and adolescents without dyslipidemia | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation of the branchial artery | Non-invasive ultrasound assessment of endothelial function. | At subject enrollment | 
| Carotid intima-media thickness | Non-invasive ultrasound assessment of early vascular disease. | At subject enrollment | 
| Measurement of cystatin C in serum | Cystatin C is a marker for assessing renal function | At subject enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abnormal levels of lipoprotein a. |  | At subject enrollment | 
| Levels of β2-microglobulin in urine | Assessment of tubular function of the kidneys. | At subject enrollment | 
| Serum creatinine levels | Assessment of renal function | At subject enrollment | 
| Assessment of eGFR |  | At subject enrollment |