NCT01086137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

March 11, 2010

Last Update Submit

August 5, 2013

Conditions

Metabolic SyndromeDiabetesPrediabetesHypertension

Keywords

salivary biomarkermetabolic syndromeprediabetesdiabetes hypertension

Outcome Measures

Primary Outcomes (1)

  • Salivary Biomarker Levels

    baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia School of Osteopathic Medicine

Lewisburg, West Virginia, 24901, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusPrediabetic StateHypertension

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kristie G Bridges, PhD

    WVSOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

US(1)