Study of Chronic Degenerative Diseases

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.

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Key information

Conditions

Metabolic Syndrome X Amino Acid Metabolism, Inborn Errors Avitaminosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Dyslipidemias Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperglycemia Hyperhomocysteinemia Hyperinsulinism Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Malabsorption Syndromes Malnutrition Metabolic Diseases Metabolic Syndrome Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Vascular Diseases Vitamin B Deficiency

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asociación Científica Latina A.C.

Toluca, State of Mexico, 50120, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary school students of medium-low income.

Exclusion criteria

Children with disabilities or a known chronic disease.

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Asociación Científica Latina A.C.

Other

Collaborators

Ciprés Grupo Médico CGM SC
Universidad Autonoma del Estado de Mexico

Registry information

Official study title

Study of Chronic Degenerative Diseases, Translational Medicine Approach

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jul 13, 2015
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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