Prevent CardioKids
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Vascular function measured by peripheral arterial tonometry (EndoPAT)
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Vascular function measured by peripheral arterial tonometry (EndoPAT)
Time Frame: 1 year
The primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups.
Secondary Outcomes
- Differences in characteristics of the microcirculation as measured via fundus photography(1 year)
- Differences in characteristics of microcirculation measured via lipoprotein profiles(1 year)
- Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles(1 year)