Metabolic SyndromeNCT01086137
Biomarkers of Metabolic Syndrome and Prediabetes
An observational study of Metabolic Syndrome and Diabetes, run by West Virginia School of Osteopathic Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes, Prediabetes
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901
About this study
Official title: Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome
The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.
- Conditions
- Metabolic Syndrome, Diabetes, Prediabetes, Hypertension
- Keywords
- salivary biomarker, metabolic syndrome, prediabetes, diabetes hypertension
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Prediabetic State, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Biomarker Levels
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia School of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristie Bridges, West Virginia School of Osteopathic Medicine
- Investigators
- Kristie G Bridges, PhD, Principal investigator, WVSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086137
- Sponsor's protocol ID
- BCS-100.1
- Other IDs
- KB01082010
- Status last verified
- Aug 2013
- First submitted
- 11 Mar 2010
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01086137
- Acronym / sponsor ID
- BCS-100.1
- Conditions
- Metabolic Syndrome, Diabetes, Prediabetes, Hypertension
- Keywords
- salivary biomarker, metabolic syndrome, prediabetes, diabetes hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- West Virginia School of Osteopathic MedicineUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary Biomarker Levels
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristie G Bridges, PhD principal investigator
WVSOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Diabetes, run by West Virginia School of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Biomarker Levels (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.