Microvascular Reactivity in Prepubertal Children
MicroChild
Microcirculation, Adiposity, and Traditional and Emerging Cardiovascular Risk Factors in Prepubertal Children
1 other identifier
observational
98
0 countries
N/A
Brief Summary
This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 21, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedMay 31, 2017
May 1, 2017
1.1 years
May 21, 2017
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Study Arms (3)
Controls
eutrophic children
Overweight
Overweight children
Obese
Obese children
Interventions
non-invasive nailfold videocapillaroscopy
blood sample collection to asses leptin and C-reactive protein
Eligibility Criteria
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.
You may qualify if:
- children aged from 5 to 10 years at prepubertal Tanner´s status
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rio de Janeiro State Universitylead
- Eliete Bouskelacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 21, 2017
First Posted
May 31, 2017
Study Start
January 1, 2013
Primary Completion
February 1, 2014
Study Completion
April 1, 2014
Last Updated
May 31, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share