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Biomarkers of Metabolic Syndrome and Prediabetes

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.
 
ClinicalTrials.gov Identifier: NCT01086137
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Kristie Bridges, West Virginia School of Osteopathic Medicine

Study Description
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Brief Summary:
The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.

Condition or disease
Metabolic Syndrome Diabetes Prediabetes Hypertension

Study Design
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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Salivary Biomarker Levels [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
saliva

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 65 years
  • Males and females will be included in this study
  • All ethnic backgrounds will be included in this study
  • Acceptable health based on interview and medical history
  • Ability to comply with requirements of the study
  • Ability and willingness to provide signed informed consent

Exclusion Criteria:

  • Eating or drinking anything but water within 10 hours of sample collection
  • Autoimmune disease
  • Type 1 diabetes
  • Pregnancy (< 6 weeks postpartum)
  • History of Sjorgren's Syndrome
  • Dental work within the last two weeks
  • Ongoing or active parasitic, fungal, viral or bacterial infection
Contacts and Locations
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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): NCT01086137


Locations
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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
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Principal Investigator: Kristie G Bridges, PhD WVSOM
More Information
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Responsible Party: Kristie Bridges, Associate Professor, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01086137    
Other Study ID Numbers: BCS-100.1
KB01082010 ( Other Identifier: WVSOM )
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Keywords provided by Kristie Bridges, West Virginia School of Osteopathic Medicine:
salivary biomarker
metabolic syndrome
prediabetes
diabetes hypertension
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Prediabetic State
Glucose Intolerance
Syndrome
Disease
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia