Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Terminated

• Conditions: Metabolic Syndrome; Obesity

• Registration Number: NCT01465789
• Lead Sponsor: West Virginia School of Osteopathic Medicine

Brief Summary

The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Participating in the CARDIAC Boot Camp Program
• Between the ages of 4 and 17
• Parental permission
• Ability to provide assent

Exclusion Criteria

• Inability to comply with saliva collection procedures
• Renal insufficiency or juvenile gout

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children	Baseline
Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence	final assessment at age 18 (up to 14 years depending on age of enrollment)

Trial Locations

Locations (1)

West Virginia School of Osteopathic Medicine; 🇺🇸 Lewisburg, West Virginia, United States