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The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03856476
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
University Hospital, Ioannina
Information provided by (Responsible Party):
Chrysoula Kosmeri, University of Ioannina

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.

Condition or disease
Dyslipidemias Children, Only Endothelial Dysfunction Renal Dysfunction Hypercholesteremia in Children

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Dyslipidemia group
Children and adolescents with dyslipidemia
Control group
Children and adolescents without dyslipidemia

Primary Outcome Measures :
  1. Flow-mediated dilation of the branchial artery [ Time Frame: At subject enrollment ]
    Non-invasive ultrasound assessment of endothelial function.

  2. Carotid intima-media thickness [ Time Frame: At subject enrollment ]
    Non-invasive ultrasound assessment of early vascular disease.

  3. Measurement of cystatin C in serum [ Time Frame: At subject enrollment ]
    Cystatin C is a marker for assessing renal function

Secondary Outcome Measures :
  1. Number of participants with abnormal levels of lipoprotein a. [ Time Frame: At subject enrollment ]
  2. Levels of β2-microglobulin in urine [ Time Frame: At subject enrollment ]
    Assessment of tubular function of the kidneys.

  3. Serum creatinine levels [ Time Frame: At subject enrollment ]
    Assessment of renal function

  4. Assessment of eGFR [ Time Frame: At subject enrollment ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03856476

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Contact: Chrysoula Kosmeri 00306932431730
Contact: Ekaterini Siomou

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University of Ioannina Recruiting
Ioánnina, Greece, 45500
Contact: Chrysoula Kosmeri   
Contact: Ekaterini Siomou   
Sponsors and Collaborators
University of Ioannina
University Hospital, Ioannina

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Responsible Party: Chrysoula Kosmeri, Principal Investigator, University of Ioannina Identifier: NCT03856476     History of Changes
Other Study ID Numbers: 234
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases