Microvascular Reactivity in Prepubertal Children

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status.

Detailed Description
-----------------
The investigators aimed to investigate microvascular reactivity in prepubertal and to compare these data in different groups according to adiposity status. Firstly, The investigators recruited only children from 5 to 10 years at prepubertal status. After excluding those with exclusion criteria and the acceptance (from their parents) to participate in the study, a blood sample was collected and an appointment at BioVasc lab was programmed. At this day, participants were subject to nail fold videocapillaroscopy. A method used to investigate microvascular reactivity by a non-invasive mean. After this, participants children were followed to the outpatient's care unit to continue follow-up.

Official Title
-----------------
Microcirculation, Adiposity, and Traditional and Emerging Cardiovascular Risk Factors in Prepubertal Children

Conditions
-----------------
Child, Only, Obesity, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: nailfold videocapillaroscopy
* Diagnostic Test: inflammatory biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged from 5 to 10 years at prepubertal Tanner´s status Exclusion Criteria: puberty regular use of any medication hypertension heart disease renal and blood diseases .the presence of any acute or chronic inflammatory/infectious diseases. .presence of diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>eutrophic children | Diagnostic Test: nailfold videocapillaroscopy<br>* non-invasive nailfold videocapillaroscopy<br>* Other names: controls, overweight and obese groups;Diagnostic Test: inflammatory biomarkers<br>* blood sample collection to asses leptin and C-reactive protein<br>* Other names: controls, overweight and obese groups;|
| Overweight<br>Overweight children | Diagnostic Test: nailfold videocapillaroscopy<br>* non-invasive nailfold videocapillaroscopy<br>* Other names: controls, overweight and obese groups;Diagnostic Test: inflammatory biomarkers<br>* blood sample collection to asses leptin and C-reactive protein<br>* Other names: controls, overweight and obese groups;|
| Obese<br>Obese children | Diagnostic Test: nailfold videocapillaroscopy<br>* non-invasive nailfold videocapillaroscopy<br>* Other names: controls, overweight and obese groups;Diagnostic Test: inflammatory biomarkers<br>* blood sample collection to asses leptin and C-reactive protein<br>* Other names: controls, overweight and obese groups;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular reactivity by nail fold videocapillaroscopy | Nailfold videocapillaroscopy is performed using the fourth finger of the left hand in a temperature-controlled environment (22ºC). The following microvascular parameters are determined at resting state: (a) functional capillary density (FCD), the number of capillaries/mm2 with red blood cell flux, evaluated with 250x magnification in a 3-mm area of the distal row of capillaries in three different areas (lateral, central and medial); (b) red blood cell velocity at rest (RBCV) and during post occlusive reactive hyperemia (PORH); c) the peak RBCV after 1-min arterial occlusion (RBCVmax); and (d) the time taken to reach RBCVmax (TRBCVmax). Firstly, a pressure cuff (1-cm wide) is placed around the proximal phalanx and connected to a mercury manometer. | 24 months from the beginning of the recruitment period until the ending of the manuscript. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariate analysis using Canonical Discriminant analysis | Univariate intergroup comparisons are performed by ANOVA or Kruskal-Wallis tests according to whether the tested variables followed a normal or non-normal distribution, respectively. Post hoc Bonferroni and Dunn tests were then performed. Biological systems, as many processes in nature, are inherently multivariate, therefore, a multivariate approach to determine which variables discriminate between the groups is taken and then the investigators applies Canonical Discriminant Function Analysis. This analysis determines how well it is possible to distinguish groups from a multivariate data set. The variation of a specific physiological parameter may influence other parameters and their synergistic action can generate results not easily detectable through a univariate analysis. The level of significance adopted was 0.05. | 24 months from the beginning of the recruitment period until the ending of the manuscript. | 
| Inflammatory and biochemical biomarkers | Laboratory testing includes fasting plasma glucose, insulin, total cholesterol and HDL-cholesterol, triglycerides, leptin, adiponectin, high sensitivity C-reactive protein, and interleukin-6 levels. Biochemical analysis is performed using the following methods: for FPG, the GOD-PAP enzymatic (oxidase); for cholesterol, the CHOP-POD enzymatic (esterase-oxidase); for triglycerides, the GPO/PAP enzymatic (oxidase); and for HDL-cholesterol, the colorimetric without precipitation. Insulin, leptin and adiponectin levels are measured using a solid phase radioimmunoassay. Interleukin-6 level is measured by the electrochemiluminescence method and Hs-CRP level is measured by the turbidimetric method. | 24 months from the beginning of the recruitment period until the ending of the manuscript. |