Study of Chronic Degenerative Diseases

Metabolic Syndrome X Clinical Trial

Official title:

Study of Chronic Degenerative Diseases, Translational Medicine Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495961
• Other study ID #: 2014-01
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: February 15, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Asociación Científica Latina A.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review BoardColombia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Primary school students of medium-low income.

Exclusion Criteria:

• Children with disabilities or a known chronic disease.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome X

Locations

Country	Name	City	State
Mexico	Asociación Científica Latina A.C.	Toluca	State of Mexico

Sponsors (3)

Lead Sponsor	Collaborator
Asociación Científica Latina A.C.	Ciprés Grupo Médico CGM SC, Universidad Autonoma del Estado de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome component detection	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).	six months	No