Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01465789

Enrollment

Registered

2011-11-07

Start date

2011-07-31

Completion date

2013-06-30

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Outcome results