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Study of Chronic Degenerative Diseases

Study of Chronic Degenerative Diseases, Translational Medicine Approach

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02495961
Enrollment
57
Registered
2015-07-13
Start date
2015-06-30
Completion date
2016-02-29
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

hyperlipidemias, hyperglycemia, hypertension, leptin, hyperhomocysteinemia

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.

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.

Interventions

None listed

Sponsors

Universidad Autonoma del Estado de Mexico
CollaboratorOTHER
Ciprés Grupo Médico CGM SC
CollaboratorOTHER
Asociación Científica Latina A.C.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Primary school students of medium-low income.

Exclusion criteria

* Children with disabilities or a known chronic disease.

Design outcomes

Primary

MeasureTime frameDescription
Metabolic syndrome component detectionsix monthsAfter 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).

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026