DyslipidemiasNCT03856476
The Effect of Childhood Dyslipidemia on Endothelial and Renal Function
An observational study of Dyslipidemias and Children, Only, run by University of Ioannina at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Children, Only, Endothelial Dysfunction
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 3 Apr 2017to 3 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- History of renal disease
- Dyslipidemia caused by nephrotic syndrome or chronic kidney disease
- Chronic use of medication
- Acute or chronic inflammatory process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia
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.
Read the 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.
- Conditions
- Dyslipidemias, Children, Only, Endothelial Dysfunction, Renal Dysfunction, Hypercholesteremia in Children
- Medical subject headings
- Dyslipidemias, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dyslipidemia group | Children and adolescents with dyslipidemia | |
| Control group | Children and adolescents without dyslipidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the branchial artery
Non-invasive ultrasound assessment of endothelial function.
Measured: At subject enrollment
Carotid intima-media thickness
Non-invasive ultrasound assessment of early vascular disease.
Measured: At subject enrollment
Measurement of cystatin C in serum
Cystatin C is a marker for assessing renal function
Measured: At subject enrollment
Secondary outcomes (4)
Number of participants with abnormal levels of lipoprotein a.
Measured: At subject enrollment
Levels of β2-microglobulin in urine
Assessment of tubular function of the kidneys.
Measured: At subject enrollment
Serum creatinine levels
Assessment of renal function
Measured: At subject enrollment
Assessment of eGFR
Measured: At subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start3 Apr 2017
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina
- Responsible party
- Principal investigator, Chrysoula Kosmeri, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856476
- Sponsor's protocol ID
- 234
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30066344Kosmeri 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.
PubMed 33478934
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Markers of Endothelial and Renal Dysfunction in Children With Dyslipidemia
- ClinicalTrials.gov ID
- NCT03856476
- Acronym / sponsor ID
- 234
- Conditions
- Dyslipidemias, Children, Only, Endothelial Dysfunction, Renal Dysfunction, Hypercholesteremia in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyslipidemia group | – | –Children and adolescents with dyslipidemia |
| Control group | – | –Children and adolescents without dyslipidemia |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- History of renal disease
- Dyslipidemia caused by nephrotic syndrome or chronic kidney disease
- Chronic use of medication
- Acute or chronic inflammatory process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Serum creatinine levels
Time frame: At subject enrollment
Assessment of eGFR
Time frame: At subject enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 30066344Kosmeri 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.
- Derived from this study: PubMed 33478934Kosmeri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias and Children, Only, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation of the branchial artery (time frame: At subject enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856476, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.