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Completed

NCT Number: NCT04181398

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

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)

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Key information

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Brussels

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anthropometry

Diagnostic Test
  • 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.

blood pressure

Diagnostic Test

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.

Peripheral arterial tonometry

Diagnostic Test

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).

Questionnaire

Other

General questionnaire on cardiovascular risk factors

Blood sample

Diagnostic Test

Blood sample for hs-CRP

Primary outcomes

  1. Endothelial cell function

    Time frame: through study completion, an average of 1 year (measured once)

    Reactive hyperemia index (RHI) measured by the EndoPAT device.

Secondary outcomes

  1. hs CRP level

    Time frame: through 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.

  2. BMI z-score

    Time frame: through 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

  3. Fat percentage by skin fold measurements

    Time frame: through 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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2019
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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