Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

Conditions
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Metabolic Syndrome, Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with ≧ one of the following criteria of metabolic syndrome weist circumstance ≧90th percentile TG≧150 mg/dL HDL<40 mg/dL BP>≧90th percentile A.C. glucose>100 mg/dL or T2D Volunteer Exclusion Criteria: inability to complete study procedures pregnancy malignancy.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study<br>children aged 6-18 years with pre-metabolic syndrome | |
| control<br>children aged 6-18 years without pre-metabolic syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymmetric dimethylarginine (ADMA) | Differences of ADMA level (μM) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiponectin | Differences of adiponectin level (μg/mL) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment | 
| β-trace protein (BTP) | Differences of BTP level (mg/dL) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment | 
| Flow-mediated dilation (FMD) | Differences of FMD (%) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment | 
| Pulse wave velocity (PWV) | Differences of PWV (m/s) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment | 
| Ambulatory arterial stiffness index (AASI) | Differences of AASI (unit) in children with pre-Metabolic syndrome vs. control. | At the time of enrollment |