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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04181398
• Other study ID #: Palomino
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Endothelial Dysfunction
• Inflammation
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Belgium	University Hospital of Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell function	Reactive hyperemia index (RHI) measured by the EndoPAT device.	through study completion, an average of 1 year (measured once)
Secondary	hs CRP level	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)
Secondary	BMI z-score	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)
Secondary	Fat percentage by skin fold measurements	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)