Ignite Creation Date:
2024-05-06 @ 7:13 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02495961
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-07-09
Brief Title:
Study of Chronic Degenerative Diseases
Sponsor:
Asociación Científica Latina AC
Organization:
Asociación Científica Latina AC
Study Overview
Official Title:
Study of Chronic Degenerative Diseases Translational Medicine Approach
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 005 and a beta of 02 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 005 The statistical program used is the Statistical Package for the Social Sciences SPSS version 19
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 005 and a beta of 02 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 005 The statistical program used is the Statistical Package for the Social Sciences SPSS version 19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None