Obesity, ChildhoodNCT04181398
Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
A study testing Anthropometry, Blood pressure and Peripheral arterial tonometry in people with Obesity, Childhood and Obesity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Eligible candidates will be recruited within the children with overweight and obesity having a metabolic risk evaluation before treatment in the period 2006 and 2010 at the pediatric clinic of the UZ Brussel In total 60 participants will be investigated. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Obesity, Childhood, Obesity, Endothelial Dysfunction
- What is being tested?
- Anthropometry, Blood pressure and Peripheral arterial tonometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Interventional
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-21 years at the moment of evaluation
- BMI > 1.3 Standard Deviation Score at the initial evaluation
- Hs-CRP available at initial evaluation
Who cannot join
- Acute of chronic Infection at the time of the study visit
- Be or have been a smoker of tabacco
Trial locations and contacts
1 site in 1 country.
About this study
Eligible candidates will be recruited within the children with overweight and obesity having a metabolic risk evaluation before treatment in the period 2006 and 2010 at the pediatric clinic of the UZ Brussel In total 60 participants will be investigated. Firstly, 30 participating patients with initially elevated hsCRP will be selected at random ( following the date of their initial investigation) and afterwards matched for age, BMI z-score, and blood pressure with the same number of patients without initially elevated hCRP values
Data will be collected as follows:
- questionnaires
- clinical examination/ anthropometry
- blood sample (hsCRP)
- peripheral arterial tonometry (endoPAT)
Read the detailed description
Obesity and overweight have become an important health burden in children and adolescents, with 19% of all children between 5 and 18 years being either obese or overweight in Belgium. Obesity and especially visceral adiposity early in life may contribute to the development of cardiovascular disease at older age, as it shows tracking into adulthood and is be associated with cardiovascular risk factors such as dyslipidemia, insulin resistance, arterial hypertension and low grade inflammation, in a variable percentage.
Low grade inflammation, as assessed by hSCRP, was found to be present in 20.6 % and 19.8 % of overweight children and adolescents. In adults, hSCRP levels between 1 and 3 mg/L and above 3 mg/L are considered coronary disease risk factors.
Endothelial dysfunction, know to precede the formation of atherosclerotic plaque, can be assessed in a non-invasive manner in children by peripheral artery tonometry. Only few studies have been performed in obese children with this bed-side technique, showing either normal of a disturbed function, reflected by a lower reactive hyperemia index. The association with low grade inflammation however was assessed in only one study. The investigators hypothesize that in adolescents and young adults with a history of childhood obesity a more disturbed endothelial function will be present in those with and /or current elevated hSCRP value.
- Conditions
- Obesity, Childhood, Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor, Inflammation
- Being tested
- Anthropometry, Blood pressure, Peripheral arterial tonometry, Questionnaire, Blood sample
- Medical subject headings
- Pediatric Obesity, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthropometryDiagnostic test
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio will be calculated from measured height and waist circumference.
Blood pressureDiagnostic test
Blood pressure will be measured using an oscillometric, electronic device (Mindray). The blood pressure will be measured 3 times; the first measurement will not be taken into account and the mean of the second and third measurement will be considered as the real blood pressure.
Peripheral arterial tonometryDiagnostic test
The investigator will measure the pulse wave amplitude by using a finger plethysmograph (peripheral arterial tonometry). The investigator will use the EndoPAT device from Itamar Medical Ltd. At the end of the examination, the participants will be asked to give a VAS-score (Visual Analogue Pain scale).
QuestionnaireOther
General questionnaire on cardiovascular risk factors
Blood sampleDiagnostic test
Blood sample for hs-CRP
| Study group | Role | What they receive |
|---|---|---|
| Baseline high hs-CRP | Experimental | Anthropometry:
* Actual Height and weight
* Calculated BMI from measured weight and height.
* Pubertal development (Tanner stage)
* Waist circumference
* Skin fold measurement (Triceps and Subscapular)
* Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP) Receives: Diagnostic Test: Anthropometry; Diagnostic Test: Blood pressure; Diagnostic Test: Peripheral arterial tonometry; Other: Questionnaire; Diagnostic Test: Blood sample |
| Baseline low hs-CRP | Experimental | Anthropometry:
* Actual Height and weight
* Calculated BMI from measured weight and height.
* Pubertal development (Tanner stage)
* Waist circumference
* Skin fold measurement (Triceps and Subscapular)
* Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP) Receives: Diagnostic Test: Anthropometry; Diagnostic Test: Blood pressure; Diagnostic Test: Peripheral arterial tonometry; Other: Questionnaire; Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell function
Reactive hyperemia index (RHI) measured by the EndoPAT device.
Measured: through study completion, an average of 1 year (measured once)
Secondary outcomes (3)
hs CRP level
The investigators also hypothesized that low grade inflammation, and thus a rise in hs-CRP, will be persistent overtime.
Measured: through study completion, an average of 1 year (measured once)
BMI z-score
The researchers want to investigate the evolution of the level of the obesity of the participants over time
Measured: through study completion, an average of 1 year (measured once)
Fat percentage by skin fold measurements
The researchers want to investigate the evolution of the level of the obesity of the participants over time
Measured: through study completion, an average of 1 year (measured once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Observational cohort study without blinding or randomization.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inge Gies, Universitair Ziekenhuis Brussel
- Investigators
- Jean De Schepper, PhD, Principal investigator, Universitair Ziekenhuis BrusselInge Gies, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181398
- Sponsor's protocol ID
- Palomino
- Status last verified
- Mar 2025
- First submitted
- 8 Aug 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT04181398
- Acronym / sponsor ID
- Palomino
- Conditions
- Obesity, Childhood, Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Nov 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.
Eligible candidates will be recruited within the children with overweight and obesity having a metabolic risk evaluation before treatment in the period 2006 and 2010 at the pediatric clinic of the UZ Brussel In total 60 participants will be investigated. Firstly, 30 participating patients with initially elevated hsCRP will be selected at random ( following the date of their initial investigation) and afterwards matched for age, BMI z-score, and blood pressure with the same number of patients without initially elevated hCRP values
Data will be collected as follows:
- questionnaires
- clinical examination/ anthropometry
- blood sample (hsCRP)
- peripheral arterial tonometry (endoPAT)
Detailed description
Obesity and overweight have become an important health burden in children and adolescents, with 19% of all children between 5 and 18 years being either obese or overweight in Belgium. Obesity and especially visceral adiposity early in life may contribute to the development of cardiovascular disease at older age, as it shows tracking into adulthood and is be associated with cardiovascular risk factors such as dyslipidemia, insulin resistance, arterial hypertension and low grade inflammation, in a variable percentage.
Low grade inflammation, as assessed by hSCRP, was found to be present in 20.6 % and 19.8 % of overweight children and adolescents. In adults, hSCRP levels between 1 and 3 mg/L and above 3 mg/L are considered coronary disease risk factors.
Endothelial dysfunction, know to precede the formation of atherosclerotic plaque, can be assessed in a non-invasive manner in children by peripheral artery tonometry. Only few studies have been performed in obese children with this bed-side technique, showing either normal of a disturbed function, reflected by a lower reactive hyperemia index. The association with low grade inflammation however was assessed in only one study. The investigators hypothesize that in adolescents and young adults with a history of childhood obesity a more disturbed endothelial function will be present in those with and /or current elevated hSCRP value.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational cohort study without blinding or randomization.
| Arm | Type | Receives |
|---|---|---|
| Baseline high hs-CRP | Experimental | Diagnostic Test: Anthropometry, Diagnostic Test: Blood pressure, Diagnostic Test: Peripheral arterial tonometry, Other: Questionnaire, Diagnostic Test: Blood sampleAnthropometry: * Actual Height and weight * Calculated BMI from measured weight and height. * Pubertal development (Tanner stage) * Waist circumference * Skin fold measurement (Triceps and Subscapular) * Waist-to-height ratio. Blood pressure (mean of 3 measurements) Peripheral arterial tonometry Questionnaire Blood sample (hsCRP) |
| Baseline low hs-CRP | Experimental | Diagnostic Test: Anthropometry, Diagnostic Test: Blood pressure, Diagnostic Test: Peripheral arterial tonometry, Other: Questionnaire, Diagnostic Test: Blood sampleAnthropometry: * Actual Height and weight * Calculated BMI from measured weight and height. * Pubertal development (Tanner stage) * Waist circumference * Skin fold measurement (Triceps and Subscapular) * Waist-to-height ratio. Blood pressure (mean of 3 measurements) Peripheral arterial tonometry Questionnaire Blood sample (hsCRP) |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12-21 years at the moment of evaluation
- BMI > 1.3 Standard Deviation Score at the initial evaluation
- Hs-CRP available at initial evaluation
Key exclusion criteria (2 listed)
- Acute of chronic Infection at the time of the study visit
- Be or have been a smoker of tabacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometry* Actual Height and weight * Calculated BMI from measured weight and height. * Pubertal development (Tanner stage) * Waist circumference * Skin fold measurement (Triceps and Subscapular) * Waist-to-height ratio will be calculated from measured height and waist circumference. | Diagnostic test | Baseline high hs-CRP, Baseline low hs-CRP |
| Blood pressureBlood pressure will be measured using an oscillometric, electronic device (Mindray). The blood pressure will be measured 3 times; the first measurement will not be taken into account and the mean of the second and third measurement will be considered as the real blood pressure. | Diagnostic test | Baseline high hs-CRP, Baseline low hs-CRP |
| Peripheral arterial tonometryThe investigator will measure the pulse wave amplitude by using a finger plethysmograph (peripheral arterial tonometry). The investigator will use the EndoPAT device from Itamar Medical Ltd. At the end of the examination, the participants will be asked to give a VAS-score (Visual Analogue Pain scale). | Diagnostic test | Baseline high hs-CRP, Baseline low hs-CRP |
| QuestionnaireGeneral questionnaire on cardiovascular risk factors | Other | Baseline high hs-CRP, Baseline low hs-CRP |
| Blood sampleBlood sample for hs-CRP | Diagnostic test | Baseline high hs-CRP, Baseline low hs-CRP |
Primary outcome
Endothelial cell function
Time frame: through study completion, an average of 1 year (measured once)
Reactive hyperemia index (RHI) measured by the EndoPAT device.
3 secondary outcomes
hs CRP level
Time frame: through study completion, an average of 1 year (measured once)
BMI z-score
Time frame: through study completion, an average of 1 year (measured once)
Fat percentage by skin fold measurements
Time frame: through study completion, an average of 1 year (measured once)
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 1 Apr 2025.
- 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.
Jean De Schepper, PhD principal investigator
Universitair Ziekenhuis Brussel
Inge Gies, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthropometry, Blood pressure and Peripheral arterial tonometry in people with Obesity, Childhood and Obesity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 inclusion and 2 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 1 Apr 2025. 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 Belgium. 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?
Endothelial cell function (time frame: through study completion, an average of 1 year (measured once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.