Evaluating vascular function in children with different weight categories
Prevent CardioKids
This study looks at how weight affects blood vessel health in kids aged 6 to 18 by comparing lean and overweight children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT02113644 on ClinicalTrials.gov |
What this trial studies
Prevent CardioKids aims to assess the presence of disturbed vascular function markers in children across various weight categories, focusing on age-related differences. The study will compare vascular function measurements and plasma biomarkers between lean and overweight/obese children. Primary endpoints include examining micro- and macro-vasculature characteristics, while secondary endpoints will explore differences in lipoprotein profiles and glucose tolerance. The study involves children aged 6 to 18 years participating in the COACH program.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 years who are overweight or obese according to IOTF criteria.
Not a fit: Patients with inflammatory diseases, allergic conditions, oncologic diseases, or congenital metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention strategies for cardiovascular disease in children.
How similar studies have performed: Other studies have shown success in evaluating vascular function in children, but this specific approach focusing on weight categories is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Anita Vreugdenhil, dr. — Maastricht University Medical Center
- Study coordinator: A. Vreugdenhil, Dr.
- Email: a.vreugdenhil@mumc.nl
- Phone: 003143-3875284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.