Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Obesity Clinical Trial

Official title:

Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465789
• Other study ID #: BCS 102.2
• Status: Terminated
• Phase: N/A
• First received: July 5, 2011
• Last updated: August 5, 2013
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: West Virginia School of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Locations

Country	Name	City	State
United States	West Virginia School of Osteopathic Medicine	Lewisburg	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia School of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children		Baseline	No
Primary	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)	No