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Clinical Trials/NCT02518854
NCT02518854
Completed
Not Applicable

Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

Chang Gung Memorial Hospital1 site in 1 country80 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Chang Gung Memorial Hospital
Enrollment
80
Locations
1
Primary Endpoint
Asymmetric dimethylarginine (ADMA)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
March 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tain, You-Lin

Dr.

Chang Gung Memorial Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • β-trace protein (BTP)(At the time of enrollment)
  • Ambulatory arterial stiffness index (AASI)(At the time of enrollment)
  • Adiponectin(At the time of enrollment)
  • Flow-mediated dilation (FMD)(At the time of enrollment)
  • Pulse wave velocity (PWV)(At the time of enrollment)

Study Sites (1)

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