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Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

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ClinicalTrials.gov Identifier: NCT01465789
Recruitment Status : Terminated (Loss of participants to follow-up)
First Posted : November 7, 2011
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Kristie Bridges, 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.

Condition or disease
Obesity Metabolic Syndrome

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
Study Start Date : July 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]
  2. 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) ]

Biospecimen Retention:   Samples Without DNA
saliva


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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465789


Locations
United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
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

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
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases