Prevent CardioKids

Recruiting

• Conditions: Cardiovascular Disease
• Interventions: Other: Lifestyle intervention

• Registration Number: NCT02113644
• Lead Sponsor: Maastricht University Medical Center

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

Study Timeline

• Study First Submitted: 2013-10-23
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight or obese children	Lifestyle intervention	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

Primary Outcome Measures

Name	Time	Method
Vascular function measured by peripheral arterial tonometry (EndoPAT)	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 Outcome Measures

Name	Time	Method
Differences in characteristics of the microcirculation as measured via fundus photography	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
Differences in characteristics of microcirculation measured via lipoprotein profiles	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
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles	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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands