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Clinical Trials/NCT03171441
NCT03171441
Completed
Not Applicable

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

Rio de Janeiro State University0 sites98 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child, Only
Sponsor
Rio de Janeiro State University
Enrollment
98
Primary Endpoint
Microvascular reactivity by nail fold videocapillaroscopy
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
April 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rio de Janeiro State University
Responsible Party
Principal Investigator
Principal Investigator

Luiz Guilherme Kraemer de Aguiar

Associate professor

Rio de Janeiro State University

Eligibility Criteria

Inclusion Criteria

  • children aged from 5 to 10 years at prepubertal Tanner´s status

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Microvascular reactivity by nail fold videocapillaroscopy

Time Frame: 24 months from the beginning of the recruitment period until the ending of the manuscript.

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.

Secondary Outcomes

  • Multivariate analysis using Canonical Discriminant analysis(24 months from the beginning of the recruitment period until the ending of the manuscript.)
  • Inflammatory and biochemical biomarkers(24 months from the beginning of the recruitment period until the ending of the manuscript.)

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