Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04181398 |
Other study ID # |
Palomino |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2019 |
Est. completion date |
December 31, 2021 |
Study information
Verified date |
May 2021 |
Source |
Universitair Ziekenhuis Brussel |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Eligible candidates will be recruited within the children with overweight and obesity having
a metabolic risk evaluation before treatment in the period 2006 and 2010 at the pediatric
clinic of the UZ Brussel In total 60 participants will be investigated. Firstly, 30
participating patients with initially elevated hsCRP will be selected at random ( following
the date of their initial investigation) and afterwards matched for age, BMI z-score, and
blood pressure with the same number of patients without initially elevated hCRP values
Data will be collected as follows:
- questionnaires
- clinical examination/ anthropometry
- blood sample (hsCRP)
- peripheral arterial tonometry (endoPAT)
Description:
Obesity and overweight have become an important health burden in children and adolescents,
with 19% of all children between 5 and 18 years being either obese or overweight in Belgium.
Obesity and especially visceral adiposity early in life may contribute to the development of
cardiovascular disease at older age, as it shows tracking into adulthood and is be associated
with cardiovascular risk factors such as dyslipidemia, insulin resistance, arterial
hypertension and low grade inflammation, in a variable percentage.
Low grade inflammation, as assessed by hSCRP, was found to be present in 20.6 % and 19.8 % of
overweight children and adolescents. In adults, hSCRP levels between 1 and 3 mg/L and above 3
mg/L are considered coronary disease risk factors.
Endothelial dysfunction, know to precede the formation of atherosclerotic plaque, can be
assessed in a non-invasive manner in children by peripheral artery tonometry. Only few
studies have been performed in obese children with this bed-side technique, showing either
normal of a disturbed function, reflected by a lower reactive hyperemia index. The
association with low grade inflammation however was assessed in only one study. The
investigators hypothesize that in adolescents and young adults with a history of childhood
obesity a more disturbed endothelial function will be present in those with and /or current
elevated hSCRP value.