Child, OnlyMicroChildNCT03171441
Microvascular Reactivity in Prepubertal Children
An observational study of Child, Only and Obesity, run by Rio de Janeiro State University.
Trial summary
This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Obesity, Endothelial Dysfunction
- What is being tested?
- nailfold videocapillaroscopy and inflammatory biomarkers
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- children aged from 5 to 10 years at prepubertal Tanner´s status
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child, Only, Obesity, Endothelial Dysfunction
- Being tested
- nailfold videocapillaroscopy, inflammatory biomarkers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nailfold videocapillaroscopyDiagnostic test
Also called controls, overweight and obese groups
non-invasive nailfold videocapillaroscopy
inflammatory biomarkersDiagnostic test
Also called controls, overweight and obese groups
blood sample collection to asses leptin and C-reactive protein
| Study group | Role | What they receive |
|---|---|---|
| Controls | eutrophic children Receives: Diagnostic Test: nailfold videocapillaroscopy; Diagnostic Test: inflammatory biomarkers | |
| Overweight | Overweight children Receives: Diagnostic Test: nailfold videocapillaroscopy; Diagnostic Test: inflammatory biomarkers | |
| Obese | Obese children Receives: Diagnostic Test: nailfold videocapillaroscopy; Diagnostic Test: inflammatory biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startJan 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eliete Bouskela
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171441
- Sponsor's protocol ID
- 2218-CEP/HUPE
- Acronym
- MicroChild
- Status last verified
- May 2017
- First submitted
- 21 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation, Adiposity, and Traditional and Emerging Cardiovascular Risk Factors in Prepubertal Children
- ClinicalTrials.gov ID
- NCT03171441
- Acronym / sponsor ID
- MicroChild / 2218-CEP/HUPE
- Conditions
- Child, Only, Obesity, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Eliete Bouskela
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Diagnostic Test: nailfold videocapillaroscopy, Diagnostic Test: inflammatory biomarkerseutrophic children |
| Overweight | – | Diagnostic Test: nailfold videocapillaroscopy, Diagnostic Test: inflammatory biomarkersOverweight children |
| Obese | – | Diagnostic Test: nailfold videocapillaroscopy, Diagnostic Test: inflammatory biomarkersObese children |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- children aged from 5 to 10 years at prepubertal Tanner´s status
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nailfold videocapillaroscopyAlso: controls, overweight and obese groupsnon-invasive nailfold videocapillaroscopy | Diagnostic test | Controls, Obese, Overweight |
| inflammatory biomarkersAlso: controls, overweight and obese groupsblood sample collection to asses leptin and C-reactive protein | Diagnostic test | Controls, Obese, Overweight |
Primary outcome
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.
2 secondary outcomes
Multivariate analysis using Canonical Discriminant analysis
Time frame: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Inflammatory and biochemical biomarkers
Time frame: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Only and Obesity, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular reactivity by nail fold videocapillaroscopy (time frame: 24 months from the beginning of the recruitment period until the ending of the manuscript.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.