The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

NCT03856476 | Completed

• 1 other identifier: 234
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Number of participants with abnormal levels of lipoprotein a.

  At subject enrollment

• Levels of β2-microglobulin in urine

  At subject enrollment

• Serum creatinine levels

  At subject enrollment

• Assessment of eGFR

  At subject enrollment

Study Arms (2)

Dyslipidemia group

Children and adolescents with dyslipidemia

Control group

Children and adolescents without dyslipidemia

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The group of children with dyslipidemia will be selected from children referred to the Outpatient Lipid Clinic for Children and Adolescents and to the Pediatric Nephrology Department of the University Hospital of Ioannina. These are centers of excellence for assessing children with dyslipidemia and renal function in Northwestern Greece. The referrals are due to abnormal lipid levels in routine blood samples or family history of dyslipidemia and/or family history of premature cardiovascular disease. The group of controls will be selected from children attending the Outpatient Pediatric Clinic of University Hospital of Ioannina for follow-up of headache, heart murmur, constipation and loss of consciousness.

You may qualify if:

• 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)

You may not qualify if:

• History of renal disease
• Dyslipidemia caused by nephrotic syndrome or chronic kidney disease
• Chronic use of medication
• Acute or chronic inflammatory process

Sponsors & Collaborators

• University of Ioannina: lead
• University Hospital, Ioannina: collaborator

Study Sites (1)

University of Ioannina

Ioannina, 45500, Greece

Location

Related Publications (2)

• 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.

  PMID: 30066344 BACKGROUND

• 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.

  PMID: 33478934 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Dyslipidemias; Renal Insufficiency

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: April 3, 2017
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)