Microvascular Reactivity in Prepubertal Children (MicroChild)

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

This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status.

Study Overview

• Status: Completed
• Conditions: Obesity; Endothelial Dysfunction; Child, Only
• Intervention / Treatment: Diagnostic test: nailfold videocapillaroscopy; Diagnostic test: inflammatory biomarkers

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.

• Study Type: Observational
• Enrollment (Actual): 98

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Fifty-two obese (26 girls/26 boys), 18 overweight (13 girls/5 boys), and 28 eutrophic or lean prepubertal children (14 girls/14 boys) aged between 5 and 10 years (mean 7.44 ± 1.22 years) were consecutively selected from our pediatric endocrinology outpatients unit at the Pedro Ernesto University Hospital assessed in a cross-sectional study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; eutrophic children	Diagnostic test: nailfold videocapillaroscopy; non-invasive nailfold videocapillaroscopy; Other Names: controls, overweight and obese groups; Diagnostic test: inflammatory biomarkers; blood sample collection to asses leptin and C-reactive protein; Other Names: controls, overweight and obese groups
Overweight; Overweight children	Diagnostic test: nailfold videocapillaroscopy; non-invasive nailfold videocapillaroscopy; Other Names: controls, overweight and obese groups; Diagnostic test: inflammatory biomarkers; blood sample collection to asses leptin and C-reactive protein; Other Names: controls, overweight and obese groups
Obese; Obese children	Diagnostic test: nailfold videocapillaroscopy; non-invasive nailfold videocapillaroscopy; Other Names: controls, overweight and obese groups; Diagnostic test: inflammatory biomarkers; blood sample collection to asses leptin and C-reactive protein; 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.

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Eliete Bouskela

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2218-CEP/HUPE

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