The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

Completed

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

• Registration Number: NCT03856476
• Lead Sponsor: University of Ioannina

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.

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Ioannina; 🇬🇷 Ioánnina, Greece