Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction

Conditions
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Obesity, Childhood, Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor, Inflammation

Intervention / Treatment
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* Diagnostic Test: Anthropometry
* Diagnostic Test: Blood pressure
* Diagnostic Test: Peripheral arterial tonometry
* Other: Questionnaire
* Diagnostic Test: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Acute of chronic Infection at the time of the study visit Be or have been a smoker of tabacco

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Observational cohort study without blinding or randomization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline high hs-CRP<br>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) | Diagnostic Test: Anthropometry<br>* 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.<br>Diagnostic Test: Blood pressure<br>* 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.<br>Diagnostic Test: Peripheral arterial tonometry<br>* 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).<br>Other: Questionnaire<br>* General questionnaire on cardiovascular risk factors<br>Diagnostic Test: Blood sample<br>* Blood sample for hs-CRP<br>|
| Experimental: Baseline low hs-CRP<br>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) | Diagnostic Test: Anthropometry<br>* 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.<br>Diagnostic Test: Blood pressure<br>* 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.<br>Diagnostic Test: Peripheral arterial tonometry<br>* 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).<br>Other: Questionnaire<br>* General questionnaire on cardiovascular risk factors<br>Diagnostic Test: Blood sample<br>* Blood sample for hs-CRP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell function | Reactive hyperemia index (RHI) measured by the EndoPAT device. | through study completion, an average of 1 year (measured once) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hs CRP level | The investigators also hypothesized that low grade inflammation, and thus a rise in hs-CRP, will be persistent overtime. | 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 | 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 | through study completion, an average of 1 year (measured once) |