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Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

This study has been terminated.
(Loss of participants to follow-up)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465789
First Posted: November 7, 2011
Last Update Posted: August 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristie Bridges, West Virginia School of Osteopathic Medicine
  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:


Further study details as provided by Kristie Bridges, 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 ]
  • 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

Enrollment: 33
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: July 5, 2011
First Posted: November 7, 2011
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