The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

Endothelial Dysfunction Clinical Trial

Official title:

Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856476
• Other study ID #: 234
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: April 3, 2020

Study information

• Verified date: November 2020
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Dyslipidemias
• Endothelial Dysfunction
• Hypercholesteremia in Children
• Hypercholesterolemia
• Renal Dysfunction
• Renal Insufficiency

Locations

Country	Name	City	State
Greece	University of Ioannina	Ioánnina

Sponsors (2)

Lead Sponsor	Collaborator
University of Ioannina	University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation of the branchial artery	Non-invasive ultrasound assessment of endothelial function.	At subject enrollment
Primary	Carotid intima-media thickness	Non-invasive ultrasound assessment of early vascular disease.	At subject enrollment
Primary	Measurement of cystatin C in serum	Cystatin C is a marker for assessing renal function	At subject enrollment
Secondary	Number of participants with abnormal levels of lipoprotein a.		At subject enrollment
Secondary	Levels of ß2-microglobulin in urine	Assessment of tubular function of the kidneys.	At subject enrollment
Secondary	Serum creatinine levels	Assessment of renal function	At subject enrollment
Secondary	Assessment of eGFR		At subject enrollment