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

NCT ID: NCT04181398

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Obesity, Childhood Obesity Endothelial Dysfunction Cardiovascular Risk Factor Inflammation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Observational cohort study without blinding or randomization.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Baseline high hs-CRP

Anthropometry:

* 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.

Blood pressure (mean of 3 measurements)

Peripheral arterial tonometry

Questionnaire

Blood sample (hsCRP)

Group Type EXPERIMENTAL

Anthropometry

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

General questionnaire on cardiovascular risk factors

Blood sample

Intervention Type DIAGNOSTIC_TEST

Blood sample for hs-CRP

Baseline low hs-CRP

Anthropometry:

* 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.

Blood pressure (mean of 3 measurements)

Peripheral arterial tonometry

Questionnaire

Blood sample (hsCRP)

Group Type EXPERIMENTAL

Anthropometry

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

General questionnaire on cardiovascular risk factors

Blood sample

Intervention Type DIAGNOSTIC_TEST

Blood sample for hs-CRP

Interventions

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Anthropometry

* 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.

Intervention Type DIAGNOSTIC_TEST

Blood 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.

Intervention Type DIAGNOSTIC_TEST

Peripheral arterial tonometry

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).

Intervention Type DIAGNOSTIC_TEST

Questionnaire

General questionnaire on cardiovascular risk factors

Intervention Type OTHER

Blood sample

Blood sample for hs-CRP

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Inge Gies

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean De Schepper, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Inge Gies, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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University Hospital of Brussels

Brussels, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Palomino

Identifier Type: -

Identifier Source: org_study_id

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