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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

July 5, 2011
November 4, 2011
July 2011
December 2021   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01465789 on ClinicalTrials.gov Archive Site
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Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

saliva
Non-Probability Sample

Children participating in the CARDIAC Boot Camp program at the Robert C. Byrd Clinic in Lewisburg WV
  • Obesity
  • Metabolic Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2021
December 2021   (final data collection date for primary outcome measure)

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
Both
4 Years to 17 Years
Yes
Contact: Kristie G Bridges, PhD 304-647-6223 kbridges@osteo.wvsom.edu
United States
 
NCT01465789
BCS 102.2
No
Kristie Bridges, West Virginia School of Osteopathic Medicine
West Virginia School of Osteopathic Medicine
Not Provided
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
West Virginia School of Osteopathic Medicine
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP