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NCT Number: NCT02113644

Prevent CardioKids

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.

Recruiting

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

Location status: Recruiting

Location contact

A Vreugdenhil, Dr

PRINCIPAL_INVESTIGATOR

A. Vreugdenhil, Dr.

CONTACT

[email protected]

0031433875284

J Rijks, Drs

SUB_INVESTIGATOR

J. Plat, Prof.dr.

SUB_INVESTIGATOR

K Karnebeek, Drs.

CONTACT

003143-3874402

K Karnebeek, Drs.

SUB_INVESTIGATOR

R. Mensink, Prof.dr.

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle intervention

Other

Primary outcomes

  1. 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

  1. Differences in characteristics of the microcirculation as measured via fundus photography

    Time frame: 1 year

    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

  2. Differences in characteristics of microcirculation measured via lipoprotein profiles

    Time frame: 1 year

    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

  3. Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

A. Vreugdenhil, Dr.

CONTACT

[email protected]

003143-3875284

K. Karnebeek, Drs.

CONTACT

003143-3874402

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2029
Study completion
2029
First posted
Apr 14, 2014
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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