Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
NCT ID: NCT04181398
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-03-01
2021-12-31
Brief Summary
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Data will be collected as follows:
* questionnaires
* clinical examination/ anthropometry
* blood sample (hsCRP)
* peripheral arterial tonometry (endoPAT)
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Baseline high hs-CRP
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)
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.
Blood pressure
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 tonometry
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).
Questionnaire
General questionnaire on cardiovascular risk factors
Blood sample
Blood sample for hs-CRP
Baseline low hs-CRP
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)
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.
Blood pressure
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 tonometry
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).
Questionnaire
General questionnaire on cardiovascular risk factors
Blood sample
Blood sample for hs-CRP
Interventions
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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.
Blood pressure
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 tonometry
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).
Questionnaire
General questionnaire on cardiovascular risk factors
Blood sample
Blood sample for hs-CRP
Eligibility Criteria
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Inclusion Criteria
* BMI \> 1.3 Standard Deviation Score at the initial evaluation
* Hs-CRP available at initial evaluation
Exclusion Criteria
* Be or have been a smoker of tabacco
12 Years
21 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Inge Gies
Professor
Principal Investigators
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Jean De Schepper, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Inge Gies, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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University Hospital of Brussels
Brussels, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Palomino
Identifier Type: -
Identifier Source: org_study_id
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