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Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction

Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04181398
Enrollment
20
Registered
2019-11-29
Start date
2019-03-01
Completion date
2021-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood, Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor, Inflammation

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.

Interventions

DIAGNOSTIC_TESTAnthropometry

* Actual Height and weight * Calculated BMI from measured weight and height. * Pubertal development (Tanner stage) * Waist circumference * Skin fold measurement (Triceps and Subscapular) * Waist-to-height ratio will be calculated from measured height and waist circumference.

DIAGNOSTIC_TESTBlood pressure

Blood pressure will be measured using an oscillometric, electronic device (Mindray). The blood pressure will be measured 3 times; the first measurement will not be taken into account and the mean of the second and third measurement will be considered as the real blood pressure.

The investigator will measure the pulse wave amplitude by using a finger plethysmograph (peripheral arterial tonometry). The investigator will use the EndoPAT device from Itamar Medical Ltd. At the end of the examination, the participants will be asked to give a VAS-score (Visual Analogue Pain scale).

OTHERQuestionnaire

General questionnaire on cardiovascular risk factors

DIAGNOSTIC_TESTBlood sample

Blood sample for hs-CRP

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Observational cohort study without blinding or randomization.

Eligibility

Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial cell functionthrough study completion, an average of 1 year (measured once)Reactive hyperemia index (RHI) measured by the EndoPAT device.

Secondary

MeasureTime frameDescription
hs CRP levelthrough study completion, an average of 1 year (measured once)The investigators also hypothesized that low grade inflammation, and thus a rise in hs-CRP, will be persistent overtime.
BMI z-scorethrough study completion, an average of 1 year (measured once)The researchers want to investigate the evolution of the level of the obesity of the participants over time
Fat percentage by skin fold measurementsthrough study completion, an average of 1 year (measured once)The researchers want to investigate the evolution of the level of the obesity of the participants over time

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026