Clinical trial NCT02518854: Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome
Official title: Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Cardiovascular Disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6-18 years visit pediatric nephrology clinic during study period

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.

Eligibility 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.

Primary outcomes:
measure: Asymmetric dimethylarginine (ADMA)
timeFrame: At the time of enrollment
Secondary outcomes:
measure: Adiponectin
timeFrame: At the time of enrollment
measure: β-trace protein (BTP)
timeFrame: At the time of enrollment
measure: Flow-mediated dilation (FMD)
timeFrame: At the time of enrollment
measure: Pulse wave velocity (PWV)
timeFrame: At the time of enrollment
measure: Ambulatory arterial stiffness index (AASI)
timeFrame: At the time of enrollment
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: You-Lin Tain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: