The Effect of Childhood Dyslipidemia on Endothelial and Renal Function
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|ClinicalTrials.gov Identifier: NCT03856476|
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease|
|Dyslipidemias Children, Only Endothelial Dysfunction Renal Dysfunction Hypercholesteremia in Children|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||April 3, 2020|
|Estimated Study Completion Date :||April 3, 2020|
Children and adolescents with dyslipidemia
Children and adolescents without dyslipidemia
- Flow-mediated dilation of the branchial artery [ Time Frame: At subject enrollment ]Non-invasive ultrasound assessment of endothelial function.
- Carotid intima-media thickness [ Time Frame: At subject enrollment ]Non-invasive ultrasound assessment of early vascular disease.
- Measurement of cystatin C in serum [ Time Frame: At subject enrollment ]Cystatin C is a marker for assessing renal function
- Number of participants with abnormal levels of lipoprotein a. [ Time Frame: At subject enrollment ]
- Levels of β2-microglobulin in urine [ Time Frame: At subject enrollment ]Assessment of tubular function of the kidneys.
- Serum creatinine levels [ Time Frame: At subject enrollment ]Assessment of renal function
- Assessment of eGFR [ Time Frame: At subject enrollment ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856476
|Contact: Chrysoula Kosmeriemail@example.com|
|Contact: Ekaterini Siomoufirstname.lastname@example.org|
|University of Ioannina||Recruiting|
|Ioánnina, Greece, 45500|
|Contact: Chrysoula Kosmeri email@example.com|
|Contact: Ekaterini Siomou firstname.lastname@example.org|