Prevent CardioKids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Disease. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Other Lifestyle intervention
Primary outcome measures
- Vascular function measured by peripheral arterial tonometry (EndoPAT) [Time frame: 1 year]
Secondary outcome measures (3)
- Differences in characteristics of the microcirculation as measured via fundus photography [Time frame: 1 year]
- Differences in characteristics of microcirculation measured via lipoprotein profiles [Time frame: 1 year]
- Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Netherlands · 1 center
- Maastricht University Medical Center — Maastricht
Identifiers
NCT: NCT02113644 · Prevent CardioKids