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

NCT04181398 | Completed DMC

• 1 other identifier: Palomino
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Endothelial cell function

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

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

Secondary Outcomes (3)

• hs CRP level

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

• BMI z-score

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

• Fat percentage by skin fold measurements

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

Study Arms (2)

Baseline high hs-CRP

EXPERIMENTAL

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; Diagnostic Test: Blood pressure; Diagnostic Test: Peripheral arterial tonometry; Other: Questionnaire; Diagnostic Test: Blood sample

Baseline low hs-CRP

EXPERIMENTAL

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; Diagnostic Test: Blood pressure; Diagnostic Test: Peripheral arterial tonometry; Other: Questionnaire; Diagnostic Test: Blood sample

Interventions

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.

Baseline high hs-CRP; Baseline low hs-CRP

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.

Baseline high hs-CRP; Baseline low hs-CRP

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).

Baseline high hs-CRP; Baseline low hs-CRP

Questionnaire OTHER

General questionnaire on cardiovascular risk factors

Baseline high hs-CRP; Baseline low hs-CRP

Blood sample DIAGNOSTIC_TEST

Blood sample for hs-CRP

Baseline high hs-CRP; Baseline low hs-CRP

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Acute of chronic Infection at the time of the study visit
• Be or have been a smoker of tabacco

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

University Hospital of Brussels

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Inflammation

Interventions

Anthropometry; Blood Pressure; Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Jean De Schepper, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Inge Gies, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Observational cohort study without blinding or randomization.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: November 29, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)