Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

NCT01465789 | Terminated

• 1 other identifier: BCS 102.2
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children participating in the CARDIAC Boot Camp program at the Robert C. Byrd Clinic in Lewisburg WV

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia School of Osteopathic Medicine: lead

Study Sites (1)

West Virginia School of Osteopathic Medicine

Lewisburg, West Virginia, 24901, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Kristie G Bridges, PhD

  West Virginia School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

• Jill Cochran, PhD, MSN, RN-C FNP

  West Virginia School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: November 7, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

US (1)