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

May 3, 2021 updated by: Inge Gies, Universitair Ziekenhuis Brussel

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • University Hospital of Brussels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Diagnostic test: 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.
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.
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).
Other: Questionnaire
General questionnaire on cardiovascular risk factors
Diagnostic test: Blood sample
Blood sample for hs-CRP
EXPERIMENTAL: 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)
Diagnostic test: 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.
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.
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).
Other: Questionnaire
General questionnaire on cardiovascular risk factors
Diagnostic test: Blood sample
Blood sample for hs-CRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell function
Time Frame: through study completion, an average of 1 year (measured once)
Reactive hyperemia index (RHI) measured by the EndoPAT device.
through study completion, an average of 1 year (measured once)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year (measured once)
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
through study completion, an average of 1 year (measured once)
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
through study completion, an average of 1 year (measured once)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Jean De Schepper, PhD, Universitair Ziekenhuis Brussel
  • Principal Investigator: Inge Gies, PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (ACTUAL)

November 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Palomino

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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