The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

University of Ioannina

Status: Completed

Conditions: Hypercholesteremia in Children; Endothelial Dysfunction; Dyslipidemias; Children, Only; Renal Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT03856476

234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Dyslipidemia group

Description:

Children and adolescents with dyslipidemia

Control group

Description:

Children and adolescents without dyslipidemia