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Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

This study is currently recruiting participants.
Verified November 2011 by West Virginia School of Osteopathic Medicine
Sponsor:
Information provided by (Responsible Party):
Kristie Bridges, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01465789
First received: July 5, 2011
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Obesity
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West Virginia School of Osteopathic Medicine:

Primary Outcome Measures:
  • Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence [ Time Frame: final assessment at age 18 (up to 14 years depending on age of enrollment) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

saliva


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465789

Contacts
Contact: Kristie G Bridges, PhD 304-647-6223 kbridges@osteo.wvsom.edu

Locations
United States, West Virginia
West Virginia School of Osteopathic Medicine Recruiting
Lewisburg, West Virginia, United States, 24901
Contact: Kristie Bridges, PhD     304-647-6223     kbridges@osteo.wvsom.edu    
Sponsors and Collaborators
West Virginia School of Osteopathic Medicine
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Kristie Bridges, Associate Professor, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01465789     History of Changes
Other Study ID Numbers: BCS 102.2
Study First Received: July 5, 2011
Last Updated: November 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013