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Trial record 33 of 129 for:    PAP children

Microvascular Reactivity in Prepubertal Children (MicroChild)

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ClinicalTrials.gov Identifier: NCT03171441
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Eliete Bouskela
Information provided by (Responsible Party):
Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University

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

Condition or disease Intervention/treatment
Child, Only Obesity Endothelial Dysfunction 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
Actual Enrollment : 98 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Microcirculation, Adiposity, and Traditional and Emerging Cardiovascular Risk Factors in Prepubertal Children
Actual Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

Group/Cohort Intervention/treatment
Controls
eutrophic children
Diagnostic Test: nailfold videocapillaroscopy
non-invasive nailfold videocapillaroscopy
Other Name: controls, overweight and obese groups

Diagnostic Test: inflammatory biomarkers
blood sample collection to asses leptin and C-reactive protein
Other Name: controls, overweight and obese groups

Overweight
Overweight children
Diagnostic Test: nailfold videocapillaroscopy
non-invasive nailfold videocapillaroscopy
Other Name: controls, overweight and obese groups

Diagnostic Test: inflammatory biomarkers
blood sample collection to asses leptin and C-reactive protein
Other Name: controls, overweight and obese groups

Obese
Obese children
Diagnostic Test: nailfold videocapillaroscopy
non-invasive nailfold videocapillaroscopy
Other Name: controls, overweight and obese groups

Diagnostic Test: inflammatory biomarkers
blood sample collection to asses leptin and C-reactive protein
Other Name: controls, overweight and obese groups




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Multivariate analysis using Canonical Discriminant analysis [ Time Frame: 24 months from the beginning of the recruitment period until the ending of the manuscript. ]

    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.


  2. Inflammatory and biochemical biomarkers [ Time Frame: 24 months from the beginning of the recruitment period until the ending of the manuscript. ]
    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.



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Responsible Party: Luiz Guilherme Kraemer de Aguiar, Associate professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03171441     History of Changes
Other Study ID Numbers: 2218-CEP/HUPE
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No