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Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02518854
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tain, You-Lin, Chang Gung Memorial Hospital

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.


Condition or disease
Metabolic Syndrome Cardiovascular Disease

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome
Study Start Date : June 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
study
children aged 6-18 years with pre-metabolic syndrome
control
children aged 6-18 years without pre-metabolic syndrome



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children aged 6-18 years visit pediatric nephrology clinic during study period
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518854


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: You-Lin Tain, MD, PhD Chang Gung Memorial Hospital
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Responsible Party: Tain, You-Lin, Dr., Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02518854    
Other Study ID Numbers: 104-1970A3
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases