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NCT Number: NCT03856476

The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

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.

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Key information

Conditions

Dyslipidemias Children, Only Endothelial Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypercholesteremia in Children Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Dysfunction Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ioannina

Ioannina, 45500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Flow-mediated dilation of the branchial artery

    Time frame: At subject enrollment

    Non-invasive ultrasound assessment of endothelial function.

  2. Carotid intima-media thickness

    Time frame: At subject enrollment

    Non-invasive ultrasound assessment of early vascular disease.

  3. Measurement of cystatin C in serum

    Time frame: At subject enrollment

    Cystatin C is a marker for assessing renal function

Secondary outcomes

  1. Number of participants with abnormal levels of lipoprotein a.

    Time frame: At subject enrollment

  2. Levels of β2-microglobulin in urine

    Time frame: At subject enrollment

    Assessment of tubular function of the kidneys.

  3. Serum creatinine levels

    Time frame: At subject enrollment

    Assessment of renal function

  4. Assessment of eGFR

    Time frame: At subject enrollment

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Collaborators

  • University Hospital, Ioannina

Registry information

Official study title

Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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