Prevent CardioKids

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Cardiovascular Disease

Treatments: Other: Lifestyle intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02113644

Prevent CardioKids

Details and patient eligibility

About

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.

Full 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

Enrollment: 240 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

Overweight or obese children

Description:

Overweight or obese children according to the International Obesity Task Force (IOTF) criteria following the lifestyle intervention in the Centre for Overweight Adolescent and Children's Healthcare

Treatment:

Other: Lifestyle intervention

Lean children

Description:

Lean children according to the International Obesity Task Force (IOTF) criteria admitted at de pediatric ward for a planned surgery, for example the correction of floppy ears