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Prevent CardioKids

Prevent CardioKids

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02113644
Enrollment
240
Registered
2014-04-14
Start date
2014-04-30
Completion date
2029-04-30
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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

Interventions

OTHERLifestyle intervention

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular function measured by peripheral arterial tonometry (EndoPAT)1 yearThe primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups.

Secondary

MeasureTime frameDescription
Differences in characteristics of the microcirculation as measured via fundus photography1 yearDifferences 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
Differences in characteristics of microcirculation measured via lipoprotein profiles1 yearDifferences 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
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles1 yearDifferences 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

Countries

Netherlands

Contacts

Primary ContactA. Vreugdenhil, Dr.
a.vreugdenhil@mumc.nl003143-3875284
Backup ContactK. Karnebeek, Drs.
003143-3874402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026