Biomarkers of Metabolic Syndrome and Prediabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristie Bridges, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01086137
First received: March 11, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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


Condition
Metabolic Syndrome
Diabetes
Prediabetes
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by West Virginia School of Osteopathic Medicine:

Primary Outcome Measures:
  • Salivary Biomarker Levels [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

saliva


Enrollment: 102
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086137

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 WVSOM
  More Information

No publications provided

Responsible Party: Kristie Bridges, Associate Professor, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01086137     History of Changes
Other Study ID Numbers: BCS-100.1, KB01082010
Study First Received: March 11, 2010
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia School of Osteopathic Medicine:
salivary biomarker
metabolic syndrome
prediabetes
diabetes hypertension

Additional relevant MeSH terms:
Metabolic Syndrome X
Hypertension
Glucose Intolerance
Prediabetic State
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Diabetes Mellitus
Endocrine System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014