Clinical trial NCT04181398: Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
Official title: Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Obesity
Endothelial Dysfunction
Cardiovascular Risk Factor
Inflammation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational cohort study without blinding or randomization.
Primary purpose: SCREENING

Brief 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)

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age 12-21 years at the moment of evaluation
* BMI \> 1.3 Standard Deviation Score at the initial evaluation
* Hs-CRP available at initial evaluation

Exclusion Criteria:

* Acute of chronic Infection at the time of the study visit
* Be or have been a smoker of tabacco

Primary outcomes:
measure: Endothelial cell function
timeFrame: through study completion, an average of 1 year (measured once)
Secondary outcomes:
measure: hs CRP level
timeFrame: through study completion, an average of 1 year (measured once)
measure: BMI z-score
timeFrame: through study completion, an average of 1 year (measured once)
measure: Fat percentage by skin fold measurements
timeFrame: through study completion, an average of 1 year (measured once)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital of Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jean De Schepper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Inge Gies, PhD
role: PRINCIPAL_INVESTIGATOR
References: