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ChildrenNCT03203863

Metabolic Syndrome in Children and Adolescents

An observational study of Children and Cardiovascular, run by Pontificia Universidad Catolica de Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to cross-sectionally evaluate nutritional status and the metabolic syndrome in a sample of school-age children 10-15 years of age from 20 public schools in Santiago, Chile. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Children, Cardiovascular, Risk Factors
What is being tested?
anthropometric measures of fatness
How many people
3,325 participants
Where
No sites listed yet
Study dates
1 Apr 2009to 30 Apr 2012
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 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Initially 5,614 students were eligible for the study (2,616 females and 2,998 males) but 2,289 students refused to participate (34.5% females and 47.4% males (p <0.001)). A total of 3,325 children and adolescents who presented a signed informed consent were included. No significant differences in age and years of maternal education were found between the study subjects and those who refused to participate.

Who may be able to join

  • The study was conducted in children attending 5th and 6th grade in all 20 public schools of the Municipality of Puente Alto, Santiago, Chile. All students were invited to participate in the study. Parents or their representatives signed an informed consent form and boys/girls an informed acceptance form.

Who cannot join

  • Subjects not signing the informed consent or acceptance forms were excluded from the study.

About this study

Official title: Metabolic Syndrome in Adolescents. Associations With Endothelial Dysfunction and Early Programming Influences

The purpose of this study was to cross-sectionally evaluate nutritional status and the metabolic syndrome in a sample of school-age children 10-15 years of age from 20 public schools in Santiago, Chile. In addition, the investigators retrospectively assessed the association of those variables with perinatal variables (birth weight, birth length, and gestational age at delivery).

Read the detailed description

Subjects and methods Subjects The study was conducted in 2009-2011 in a cross-sectional way in 3,325 children attending 5th and 6th grade in 20 public schools of Santiago, Chile. All students were invited to participate in the study.

Anthropometry and other physical examinations Field measurements were performed by a nurse and a nutritionist. Height and weight were measured with children barefoot and lightly clothed using a stadiometer and a beam-scale Seca ®, with an accuracy of 50 g. The individual height and weight values were established by averaging three measurements of each parameter. BMI was calculated and expressed in percentiles and z-scores (13): z-scores were calculated according to Center for Disease Control-National Center of Statistics 2000. Nutritional status was classified according to BMI percentiles in the obese category as ≥ 95 (14). WC was measured with an inextensible tape on the upper lateral border of the right ilium in the mid-axillary line at the end of an exhalation (15) ; two measurements were averaged and the ≥ 90th percentile was used as cutoff value (16). The triceps and subscapular skin folds were measured with a Harpenden ® caliper using a standard technique (15); both were used to calculate the percentage of FM using Slaughter equations (17) previously validated in Chilean children (18, 19). Elevated FM was established as ≥ 42% for girls with 10-15 years old, ≥ 38% for boys with ≤ 12 years old, and 40% for boys with ≥ 13 years old (20).

A Critikon ® Dinamap Pro 100 BP monitor was used according to international norms and the averages of three measurements of systolic BP (SBP) were obtained and classified as abnormal using the ≥ 90 percentile of the same reference (21). A voluntary private self-report of pubertal status was requested by observation of standardized photos of breast development in girls and genitalia in boys including the presence of pubic hair (22). Maternal years of education were registered to estimate socio-economic level (23).

Blood samples Subjects were instructed to fast (water was allowed) for 12 hours prior to drawing of blood; non compliers were asked to return another day for the blood sampling. A single laboratory was used for all blood analyses at the Faculty of Medicine, Pontificia Universidad Católica de Chile.

Fasting venous blood samples were collected for determination of glucose (Gluco-quant method, Glucose / Hexokinase, Roche Diagnostics GmbH, Mannheim) and insulin (immunoassay direct luminometer chemotherapy, ADVIA Centaur ® XP, Bayer HealthCare LLC, Kyowa Medex Co. Japan); this method measures concentrations of insulin from 0.5 to 300 mUI / mL (sensitivity 0.5 mUI / mL) with a coefficient of variation of 3.48% and 6.17% for concentrations of 23.51 mUI / mL and 62.49 mUI / mL. respectively. Triglycerides and HDL-C were analyzed on the Modular Analytics P-800 platform (Roche Diagnostics GmbH, Mannheim, Germany).

Being tested
anthropometric measures of fatness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anthropometric measures of fatnessDiagnostic test

    The aim of this study was to determine the discrimination capacity for cardiovascular risk factors of BMI, fat mass (FM), waist circumference (WC), and waist to height ratio (WHtR) in a population of Chilean children from Puente Alto County. Additionally, new cutoff points were established and compared with those described by other authors

Study groups in NCT03203863
Study groupRoleWhat they receive
Puente Alto, Chile, 2009-2011.anthropometric measures of fatness
Receives: Diagnostic Test: anthropometric measures of fatness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of metabolic syndrome

    Cardiovascular risk factors for children were used with the following cutoff points: SBP ≥ 90th percentile (20), low HDL-C ≤ 40 mg/dL; TG ≥ 110 mg/dL, and ≥ 90th percentiles of a Chilean HOMA standard for children, calculated according to sex and pubertal maturation, were used to classify insulin resistance (HOMA-IR).

    Measured: At recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study start1 Apr 2009
  3. Primary completion24 Dec 2011
  4. Study completion30 Apr 2012

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
3,325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203863
Sponsor's protocol ID
13-233
Other IDs
1090594
Status last verified
Jun 2017
First submitted
19 Jun 2017
Last updated
29 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Children and Cardiovascular, run by Pontificia Universidad Catolica de Chile.

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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Presence of metabolic syndrome (time frame: At recruitment). 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 29 Jun 2017.

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