Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
57 participants
OBSERVATIONAL
2015-06-30
2016-02-29
Brief Summary
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As has already studied and published in the investigators' group, the child population of Toluca has greater expression of cardiovascular risk factors than their counterparts in Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota with new biomarkers such as homocysteine and leptin is an activity that aims to provide more metabolic data affecting young people.
Hypothesis:
After six months of follow-up there will be a greater relative risk in Mexican population to have identified another component of metabolic syndrome compared to the young population of Colombia.
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Detailed Description
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To compare the expression levels of cardiovascular risk markers in young people between 5 and 12 years of Toluca, Mexico and Bogota, Colombia.
Material and methods:
Type of study: prospective, descriptive, comparative, and longitudinal.
Sample Calculation:
For a cohort study and taking into account that in the investigators' previous publication in the Colombian population only 13% (sick rate in unexposed group) had an altered metabolic parameter; accepting an alpha risk of 0.05 and a beta of 0.2 on a risk bilateral contrast, 57 subjects were required in the exposed group (Mexican population) and 57 in unexposed to detect a minimum relative risk of 3 to find other alteration to metabolic syndrome after six months follow-up.
Measurements:
The International Physical Activity Questionnaire (IPAQ) will be applied to all children. Dietary history of three days and physical examination (height in cm , weight in kg and waist circumference in centimeters) and blood pressure (mmHg) data will be recorded. Blood samples will be taken to analyze glucose, cholesterol, HDL, triglycerides, homocysteine and leptin.
Statistics:
Variables will be tested for normality through the Kolmogorov-Smirnov and Shapiro-Wilk formulas. Variables related to the physiological and metabolic functions and anthropometric measurements will be reported in mean and standard deviation. The differences in the laboratorial and anthropometrical variables will be analyzed with the Student t test. A difference will be considered significant with a p value ≤ 0.05. The statistical program used is the Statistical Package for the Social Sciences (SPSS) version 19.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low risk population
Colombian children, between 6 and 12 years old, regular students of a Primary school.
No interventions assigned to this group
High risk population
Mexican children, between 6 and 12 years old, regular students of a Primary school.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
12 Years
ALL
Yes
Sponsors
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Universidad Autonoma del Estado de Mexico
OTHER
Ciprés Grupo Médico CGM SC
OTHER
Asociación Científica Latina A.C.
OTHER
Responsible Party
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Principal Investigators
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Hugo Mendieta Zerón, PhD.
Role: PRINCIPAL_INVESTIGATOR
Asociación Científica Latina A.C.
Locations
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Asociación Científica Latina A.C.
Toluca, State of Mexico, Mexico
Countries
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Other Identifiers
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2014-01
Identifier Type: -
Identifier Source: org_study_id
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