NCT02495961

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

July 9, 2015

Last Update Submit

February 15, 2016

Conditions

Keywords

hyperlipidemiashyperglycemiahypertensionleptinhyperhomocysteinemia

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

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Asociación Científica Latina A.C.

Toluca, State of Mexico, 50120, Mexico

Location

MeSH Terms

Conditions

Metabolic SyndromeHyperlipidemiasHyperglycemiaHypertensionHyperhomocysteinemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersVascular DiseasesCardiovascular DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Hugo Mendieta Zerón, PhD.

    Asociación Científica Latina A.C.

    PRINCIPAL INVESTIGATOR

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

Locations