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Completed

NCT Number: NCT02518854

Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Asymmetric dimethylarginine (ADMA)

    Time frame: At the time of enrollment

    Differences of ADMA level (μM) in children with pre-Metabolic syndrome vs. control.

Secondary outcomes

  1. Adiponectin

    Time frame: At the time of enrollment

    Differences of adiponectin level (μg/mL) in children with pre-Metabolic syndrome vs. control.

  2. β-trace protein (BTP)

    Time frame: At the time of enrollment

    Differences of BTP level (mg/dL) in children with pre-Metabolic syndrome vs. control.

  3. Flow-mediated dilation (FMD)

    Time frame: At the time of enrollment

    Differences of FMD (%) in children with pre-Metabolic syndrome vs. control.

  4. Pulse wave velocity (PWV)

    Time frame: At the time of enrollment

    Differences of PWV (m/s) in children with pre-Metabolic syndrome vs. control.

  5. Ambulatory arterial stiffness index (AASI)

    Time frame: At the time of enrollment

    Differences of AASI (unit) in children with pre-Metabolic syndrome vs. control.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2015
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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