Study of Chronic Degenerative Diseases
1 other identifier
observational
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 17, 2016
February 1, 2016
7 months
July 9, 2015
February 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Low risk population
Colombian children, between 6 and 12 years old, regular students of a Primary school.
High risk population
Mexican children, between 6 and 12 years old, regular students of a Primary school.
Eligibility Criteria
Primary school students.
You may qualify if:
- Primary school students of medium-low income.
You may not qualify if:
- Children with disabilities or a known chronic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asociación Científica Latina A.C.lead
- Universidad Autonoma del Estado de Mexicocollaborator
- Ciprés Grupo Médico CGM SCcollaborator
Study Sites (1)
Asociación Científica Latina A.C.
Toluca, State of Mexico, 50120, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo Mendieta Zerón, PhD.
Asociación Científica Latina A.C.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 13, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
February 17, 2016
Record last verified: 2016-02