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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Metabolic Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children aged 6-18 years visit pediatric nephrology clinic during study period

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: You-Lin Tain, MD, PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 104-1970A3