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Study of Chronic Degenerative Diseases

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ClinicalTrials.gov Identifier: NCT02495961
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC
Information provided by (Responsible Party):
Asociación Científica Latina A.C.

Brief Summary:

The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is attributable to genetic factors, clinical (waist circumference, adiposity and physical condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk, each of which represents an independent risk.

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.


Condition or disease
Metabolic Syndrome X

Detailed Description:

Objective:

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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Chronic Degenerative Diseases, Translational Medicine Approach
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Low risk population
Colombian children, between 6 and 12 years old, regular students of a Primary school.
High risk population
Mexican children, between 6 and 12 years old, regular students of a Primary school.



Primary Outcome Measures :
  1. Metabolic syndrome component detection [ Time Frame: six months ]

    After six months of a basal evaluation, children will be re-examined in each component of the metabolic syndrome.

    Metabolic syndrome component detection will be determined by the measure of glucose (mg/dl), cholesterol (mg/dl), triglycerides (mg/dl), high-density lipoproteins (HDL), waist circumference (cm), hip circumference (cm) and blood pressure (mmHg).




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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary school students.
Criteria

Inclusion Criteria:

  • Primary school students of medium-low income.

Exclusion Criteria:

  • Children with disabilities or a known chronic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495961


Locations
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Mexico
Asociación Científica Latina A.C.
Toluca, State of Mexico, Mexico, 50120
Sponsors and Collaborators
Asociación Científica Latina A.C.
Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC
Investigators
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Principal Investigator: Hugo Mendieta Zerón, PhD. Asociación Científica Latina A.C.
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Responsible Party: Asociación Científica Latina A.C.
ClinicalTrials.gov Identifier: NCT02495961    
Other Study ID Numbers: 2014-01
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Asociación Científica Latina A.C.:
hyperlipidemias
hyperglycemia
hypertension
leptin
hyperhomocysteinemia
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases