Biomarkers of Metabolic Syndrome and Prediabetes | NCT01086137

Studies
Biomarkers of Metabolic Syndrome and Prediabetes

NCT01086137

Sponsor

West Virginia School of Osteopathic Medicine

Status

Completed

Last Update Posted

Aug 7, 2013Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Metabolic Syndrome
Diabetes
Prediabetes
Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KB01082010	Other Identifier	WVSOM

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 11, 2010

First Submission Date that Met QC Criteria

Mar 11, 2010

First Posted Date

Mar 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2013

Last Update Posted Date

Aug 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristie Bridges, Associate Professor, West Virginia School of Osteopathic MedicinePrincipal Investigator

Lead Sponsor

West Virginia School of Osteopathic MedicineOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

102Actual

Measure	Description	Time Frame
Salivary Biomarker Levels		baseline

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristie G Bridges, PhD	WVSOM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West Virginia School of Osteopathic Medicine		Lewisburg	West Virginia	24901	United States

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D003920	Diabetes Mellitus
D011236	Prediabetic State
D006973	Hypertension

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided