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

Primary Purpose

Obesity, Childhood, Obesity, Endothelial Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Anthropometry
Blood pressure
Peripheral arterial tonometry
Questionnaire
Blood sample
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity, Childhood

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Brussels

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Baseline high hs-CRP

Baseline low hs-CRP

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hs CRP level
The investigators also hypothesized that low grade inflammation, and thus a rise in hs-CRP, will be persistent overtime.
BMI z-score
The researchers want to investigate the evolution of the level of the obesity of the participants over time
Fat percentage by skin fold measurements
The researchers want to investigate the evolution of the level of the obesity of the participants over time

Full Information

First Posted
August 8, 2019
Last Updated
May 3, 2021
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04181398
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor, Inflammation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Observational cohort study without blinding or randomization.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline high hs-CRP
Arm Type
Experimental
Arm Description
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)
Arm Title
Baseline low hs-CRP
Arm Type
Experimental
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Anthropometry
Intervention Description
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
Intervention Name(s)
Blood pressure
Intervention Description
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
Intervention Name(s)
Peripheral arterial tonometry
Intervention Description
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
Other
Intervention Name(s)
Questionnaire
Intervention Description
General questionnaire on cardiovascular risk factors
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood sample for hs-CRP
Primary Outcome Measure Information:
Title
Endothelial cell function
Description
Reactive hyperemia index (RHI) measured by the EndoPAT device.
Time Frame
through study completion, an average of 1 year (measured once)
Secondary Outcome Measure Information:
Title
hs CRP level
Description
The investigators also hypothesized that low grade inflammation, and thus a rise in hs-CRP, will be persistent overtime.
Time Frame
through study completion, an average of 1 year (measured once)
Title
BMI z-score
Description
The researchers want to investigate the evolution of the level of the obesity of the participants over time
Time Frame
through study completion, an average of 1 year (measured once)
Title
Fat percentage by skin fold measurements
Description
The researchers want to investigate the evolution of the level of the obesity of the participants over time
Time Frame
through study completion, an average of 1 year (measured once)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean De Schepper, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inge Gies, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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