Clinical trial NCT02495961: Study of Chronic Degenerative Diseases
Official title: Study of Chronic Degenerative Diseases, Translational Medicine Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome X
Keywords: hyperlipidemias
hyperglycemia
hypertension
leptin
hyperhomocysteinemia
Lead sponsor: Asociación Científica Latina A.C.
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma del Estado de Mexico
name: Ciprés Grupo Médico CGM SC
First posted: 2015-07-13
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary school students.

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.

Eligibility criteria: Inclusion Criteria:

* Primary school students of medium-low income.

Exclusion Criteria:

* Children with disabilities or a known chronic disease.

Primary outcomes:
measure: Metabolic syndrome component detection
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Asociación Científica Latina A.C.
state: State of Mexico
Study officials:
affiliation: Asociación Científica Latina A.C.
name: Hugo Mendieta Zerón, PhD.
role: PRINCIPAL_INVESTIGATOR
References: