Microvascular Reactivity in Prepubertal Children

Obesity Clinical Trial

— MicroChild  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171441
• Other study ID #: 2218-CEP/HUPE
• Status: Completed
• Phase: N/A
• First received: May 21, 2017
• Last updated: May 25, 2017
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2017
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child, Only
• Endothelial Dysfunction
• Obesity

Intervention

Diagnostic Test:
• nailfold videocapillaroscopy
non-invasive nailfold videocapillaroscopy
• inflammatory biomarkers
blood sample collection to asses leptin and C-reactive protein

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Eliete Bouskela

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.