Metabolic Syndrome XNCT02495961
Study of Chronic Degenerative Diseases
An observational study of Metabolic Syndrome X, run by Asociación Científica Latina A.C. at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- How many people
- 57 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary school students.
Who may be able to join
- Primary school students of medium-low income.
Who cannot join
- Children with disabilities or a known chronic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Chronic Degenerative Diseases, Translational Medicine Approach
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.
Read more
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.
Read the 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.
- Conditions
- Metabolic Syndrome X
- Keywords
- hyperlipidemias, hyperglycemia, hypertension, leptin, hyperhomocysteinemia
- Medical subject headings
- Metabolic Syndrome, Hyperlipidemias, Hyperglycemia, Hypertension, Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Científica Latina A.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Responsible party
- Sponsor
- Investigators
- Hugo Mendieta Zerón, PhD., Principal investigator, Asociación Científica Latina A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495961
- Sponsor's protocol ID
- 2014-01
- Status last verified
- Feb 2016
- First submitted
- 9 Jul 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chronic Degenerative Diseases, Translational Medicine Approach
- ClinicalTrials.gov ID
- NCT02495961
- Acronym / sponsor ID
- 2014-01
- Conditions
- Metabolic Syndrome X
- Keywords
- hyperlipidemias, hyperglycemia, hypertension, leptin, hyperhomocysteinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Asociación Científica Latina A.C.University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary school students.
Key inclusion criteria (1 listed)
- Primary school students of medium-low income.
Key exclusion criteria (1 listed)
- Children with disabilities or a known chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic syndrome component detection
Time frame: six months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Mendieta Zerón, PhD. principal investigator
Asociación Científica Latina A.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X, run by Asociación Científica Latina A.C. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome component detection (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016; AzTrials last refreshed its copy on 26 Oct 2026.