Prevent CardioKids

Study Overview
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Brief Summary
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The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.

Detailed Description
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The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.The primary endpoint is to examine the difference in micro- and macro-vasculature characteristics in children with different weight classifications (lean; overweight; obese; extreme obese; morbid obese). Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory and oral glucose tolerance profiles between different age groups, between lean and overweight/obese children and in relation with the measured micro- and macro-vasculature characteristics

Official Title
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Prevent CardioKids

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in the COACH program Aged between 6 and 18 years (at time of inclusion) Overweight or obesity according to IOTF criteria In order to be eligible to participate in the control group, a subject must meet all of the following criteria: Aged between 6 and 18 years Normal weight according to the IOTF criteria Undergo surgery for elective reasons Exclusion Criteria: Retarded children Children suffering from: Inflammatory diseases: auto-immune diseases, inflammatory bowel diseases, hepatitis, dermatitis, nephritis, pancreatitis, gastro-enteritis, vasculitis, salpingitis, arthritis, osteomyelitis, myositis, ear-nose-throat infections Allergic diseases: asthma, eczema, hay fever, food allergies Oncologic diseases Cystic fibrosis Type 1 diabetes mellitus Congenital metabolic diseases Malnourished children

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overweight or obese children<br>Overweight or obese children according to the International Obesity Task Force (IOTF) criteria following the lifestyle intervention in the Centre for Overweight Adolescent and Children's Healthcare | Other: Lifestyle intervention<br> <br> |
| Lean children<br>Lean children according to the International Obesity Task Force (IOTF) criteria admitted at de pediatric ward for a planned surgery, for example the correction of floppy ears | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function measured by peripheral arterial tonometry (EndoPAT) | The primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in characteristics of the microcirculation as measured via fundus photography | Differences in characteristics of the microcirculation as measured via fundus photography in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics | 1 year | 
| Differences in characteristics of microcirculation measured via lipoprotein profiles | Differences in characteristics of the microcirculation as measured via lipoprotein profiles in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics | 1 year | 
| Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles | Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics | 1 year |