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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856476
Other study ID # 234
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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