Clinical trial NCT02113644: Prevent CardioKids
Official title: Prevent CardioKids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight or obese children according to the International Obesity Task Force (IOTF) criteria between 6-18 years old. Overweight and obese children will be recruited in the COACH program. For the control group healthy, normal weight children between 6-18 years old.

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

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

Primary outcomes:
measure: Vascular function measured by peripheral arterial tonometry (EndoPAT)
timeFrame: 1 year
Secondary outcomes:
measure: Differences in characteristics of the microcirculation as measured via fundus photography
timeFrame: 1 year
measure: Differences in characteristics of microcirculation measured via lipoprotein profiles
timeFrame: 1 year
measure: Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Anita Vreugdenhil, dr.
role: PRINCIPAL_INVESTIGATOR
References: