Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome

NCT02518854 | Completed

• 1 other identifier: 104-1970A3
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Asymmetric dimethylarginine (ADMA)

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

  At the time of enrollment

Secondary Outcomes (5)

• Adiponectin

  At the time of enrollment

• β-trace protein (BTP)

  At the time of enrollment

• Flow-mediated dilation (FMD)

  At the time of enrollment

• Pulse wave velocity (PWV)

  At the time of enrollment

• Ambulatory arterial stiffness index (AASI)

  At the time of enrollment

Study Arms (2)

study

children aged 6-18 years with pre-metabolic syndrome

control

children aged 6-18 years without pre-metabolic syndrome

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• inability to complete study procedures
• pregnancy
• malignancy.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• You-Lin Tain, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 10, 2015
• Study Start: June 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

TW (1)