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Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02518854
Enrollment
80
Registered
2015-08-10
Start date
2015-06-30
Completion date
2017-03-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Metabolic Syndrome

Brief summary

Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world. Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals: 1\) To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.

Detailed description

Metabolic syndrome (MetS) is highly prevalent all over the world, including Taiwan. So far, there is still no standard definition of MetS for use in pediatric population. Thus MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world. MetS might originate from early life, namely developmental programming. Cardiovascular disease (CVD) is the most common comorbidity of MetS. Therefore identification of biomarkers for detecting children with high-risk to develop CVD and MetS progression is our priority. Investigators' previous studies identified some biomarkers from a variety of programming models, including asymmetric dimethylarginine (ADMA, a nitric oxide synthase inhibitor), β-trace protein (BTP, also known as lipocalin-type prostaglandin D synthase), and adiponectin. Thus, in the current study, ADMA profile, BTP, and adiponectin will be studied in children and adolescents with pre-MetS to explore their role as biomarkers to predict MetS and CVD progression. In childhood, assessment of CVD relies on endothelial function and arterial stiffness, as CV events are extremely rare. Thus, in this study investigators intend to perform a global vascular assessment (to determine endothelial function and arterial stiffness) in children with pre-MetS including 24hr ABPM, measure of pulse wave velocity (PWV) and ambulatory arterial stiffness index (AASI) to detect arterial stiffness, detection of flow mediated dilatation (FMD), and biomarkers. Investigators also intend to examine the correlation between biomarkers and these measured vascular parameters in children with preMetS. Therefore, investigators will recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals: 1\) To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* children with ≧ one of the following criteria of metabolic syndrome 1. weist circumstance ≧90th percentile 2. TG≧150 mg/dL 3. HDL\<40 mg/dL 4. BP\>≧90th percentile 5. A.C. glucose\>100 mg/dL or T2D * Volunteer

Exclusion criteria

* inability to complete study procedures * pregnancy * malignancy.

Design outcomes

Primary

MeasureTime frameDescription
Asymmetric dimethylarginine (ADMA)At the time of enrollmentDifferences of ADMA level (μM) in children with pre-Metabolic syndrome vs. control.

Secondary

MeasureTime frameDescription
AdiponectinAt the time of enrollmentDifferences of adiponectin level (μg/mL) in children with pre-Metabolic syndrome vs. control.
β-trace protein (BTP)At the time of enrollmentDifferences of BTP level (mg/dL) in children with pre-Metabolic syndrome vs. control.
Flow-mediated dilation (FMD)At the time of enrollmentDifferences of FMD (%) in children with pre-Metabolic syndrome vs. control.
Pulse wave velocity (PWV)At the time of enrollmentDifferences of PWV (m/s) in children with pre-Metabolic syndrome vs. control.
Ambulatory arterial stiffness index (AASI)At the time of enrollmentDifferences of AASI (unit) in children with pre-Metabolic syndrome vs. control.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026