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The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

NCT ID: NCT03856476

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2020-04-03

Brief Summary

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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

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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.

Conditions

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Dyslipidemias Children, Only Endothelial Dysfunction Renal Dysfunction Hypercholesteremia in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dyslipidemia group

Children and adolescents with dyslipidemia

No interventions assigned to this group

Control group

Children and adolescents without dyslipidemia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ioannina

OTHER

Sponsor Role collaborator

University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Chrysoula Kosmeri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Ioannina

Ioannina, , Greece

Site Status

Countries

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Greece

References

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Kosmeri C, Siomou E, Vlahos AP, Milionis H. Review shows that lipid disorders are associated with endothelial but not renal dysfunction in children. Acta Paediatr. 2019 Jan;108(1):19-27. doi: 10.1111/apa.14529. Epub 2018 Aug 22.

Reference Type BACKGROUND
PMID: 30066344 (View on PubMed)

Kosmeri C, Milionis H, Vlahos AP, Benekos T, Bairaktari E, Cholevas V, Siomou E. The impact of dyslipidemia on early markers of endothelial and renal dysfunction in children. J Clin Lipidol. 2021 Mar-Apr;15(2):292-300. doi: 10.1016/j.jacl.2020.12.003. Epub 2020 Dec 11.

Reference Type DERIVED
PMID: 33478934 (View on PubMed)

Other Identifiers

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234

Identifier Type: -

Identifier Source: org_study_id