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NCT01086137 Clinical Trial

Biomarkers of Metabolic Syndrome and Prediabetes

Hypertension Clinical Trial

Official title:
Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01086137
Other study ID # BCS-100.1
Secondary ID KB01082010
Status Completed
Phase N/A
First received March 11, 2010
Last updated August 5, 2013
Start date March 2010
Est. completion date December 2011

Study information
Verified date August 2013
Source West Virginia School of Osteopathic Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States West Virginia School of Osteopathic Medicine Lewisburg West Virginia

Sponsors (1)
Lead Sponsor Collaborator
West Virginia School of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary Biomarker Levels baseline No
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