Pre-diabetesNCT02673762
Salivary Transcriptome Biomarkers for Early Diabetes Detection
An observational study of Pre-diabetes and Type II Diabetes, run by PeriRx at 1 site in United States.
Trial summary
A PRoBE design study will be used to obtain saliva from patients before undergoing blood study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes of type II diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes, Type II Diabetes, Insulin Resistance
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with undiagnosed abnormal glucose metabolism undergoing clinically driven screening for pre-diabetes and type II diabetes.
Who may be able to join
- Adult patients with unknown glucose metabolism status and
- Requiring clinically driven screening for abnormal glucose metabolism and
- Outpatient status
Who cannot join
- Patients on treatment for abnormal glucose metabolism including diet and drug therapy
- Patients with a prior diagnosis of abnormal glucose metabolism
- Patients on treatment with corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Endovascular and Heart Institute
San Antonio, Texas, 78258
About this study
A PRoBE design study will be used to obtain saliva from patients before undergoing blood study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with multi-marker models for their discriminatory value for distinguishing patients with normal glucose metabolism from those with disease. Appropriate housekeeping genes will also be incorporated to allow for the measurement of relative gene expression.
Read the detailed description
Prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) methods will be employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type II diabetes identification. At risk patients will have fasting blood glucose and insulin levels measured along with hemoglobin A1c and 2 hour post-prandial glucose levels. Saliva samples will be stored and will be analyzed after pre-specifying a panel of mRNAs and a multi marker model for validation. The pre-specified mRNAs and multi-marker model will be determined after analysis of data from a currently ongoing case-control study. After analyzing the data from this prior trial a validation plan will be locked before analysis of the prospectively collected specimens. Pre-diabetes will be defined based on abnormal glucose tolerance tests. Insulin resistance will be calculated as HOMA IR. The diagnostic value of the salivary transcriptome for will be compared with that of hemoglobin A1c and fasting blood glucose for the detection of pre-diabetes, insulin resistance and type II diabetes.
- Conditions
- Pre-diabetes, Type II Diabetes, Insulin Resistance
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal glucose metabolism | Normal fasting blood glucose, 2 hour post prandial glucose, hemoglobin A1c and HOMA IR | |
| Pre-diabetes | Abnormal glucose tolerance tests and/or insulin resistance with fating blood glucose and hemoglobin A1c below type II diabetes levels | |
| Type II diabetes | Hemoglobin A1c 6.5% or greater, fasting blood glucose >125 mg/dl or 2 hour post-prandial blood glucose 200 mg/ml or greater |
What is being measured
The primary outcome is the main question the study is designed to answer.
A multi marker test score based on a pre-specified model is measured in each patient. The test score is on a scale of 0 to 1.0 and relates to the probability of disease.
The area under the ROC curve is used to determine the overall performance of the model at the completion of the study. An area over 0.7 is considered clincially significant.
Measured: At study entry
Secondary outcomes (2)
Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients
The performance of each individual marker will be determined at study completion my comparing median values between groups by nonparametric analysis. A p value of less than or equal to 0.05 is considered significant.
Measured: At study entry
Housekeeping gene Ct values on PCR analysis will be measured in individual patients
The performance of these genes will be determined based on stability within and between groups utilizing the NormFinder program. Stability values of < 0.2 will be considered significant.
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeriRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack L Martin, MD, Principal investigator, San Antonio Endovascular and Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673762
- Sponsor's protocol ID
- PeriRx003
- Status last verified
- Apr 2018
- First submitted
- 19 Dec 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Transcriptome Biomarkers for Early Diabetes Detection
- ClinicalTrials.gov ID
- NCT02673762
- Acronym / sponsor ID
- PeriRx003
- Conditions
- Pre-diabetes, Type II Diabetes, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- PeriRxIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 4 Feb 2016 (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.
A PRoBE design study will be used to obtain saliva from patients before undergoing blood study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with multi-marker models for their discriminatory value for distinguishing patients with normal glucose metabolism from those with disease. Appropriate housekeeping genes will also be incorporated to allow for the measurement of relative gene expression.
Detailed description
Prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) methods will be employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type II diabetes identification. At risk patients will have fasting blood glucose and insulin levels measured along with hemoglobin A1c and 2 hour post-prandial glucose levels. Saliva samples will be stored and will be analyzed after pre-specifying a panel of mRNAs and a multi marker model for validation. The pre-specified mRNAs and multi-marker model will be determined after analysis of data from a currently ongoing case-control study. After analyzing the data from this prior trial a validation plan will be locked before analysis of the prospectively collected specimens. Pre-diabetes will be defined based on abnormal glucose tolerance tests. Insulin resistance will be calculated as HOMA IR. The diagnostic value of the salivary transcriptome for will be compared with that of hemoglobin A1c and fasting blood glucose for the detection of pre-diabetes, insulin resistance and type II diabetes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal glucose metabolism | – | –Normal fasting blood glucose, 2 hour post prandial glucose, hemoglobin A1c and HOMA IR |
| Pre-diabetes | – | –Abnormal glucose tolerance tests and/or insulin resistance with fating blood glucose and hemoglobin A1c below type II diabetes levels |
| Type II diabetes | – | –Hemoglobin A1c 6.5% or greater, fasting blood glucose >125 mg/dl or 2 hour post-prandial blood glucose 200 mg/ml or greater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with undiagnosed abnormal glucose metabolism undergoing clinically driven screening for pre-diabetes and type II diabetes.
Key inclusion criteria (3 listed)
- Adult patients with unknown glucose metabolism status and
- Requiring clinically driven screening for abnormal glucose metabolism and
- Outpatient status
Key exclusion criteria (3 listed)
- Patients on treatment for abnormal glucose metabolism including diet and drug therapy
- Patients with a prior diagnosis of abnormal glucose metabolism
- Patients on treatment with corticosteroids
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
A multi marker test score based on a pre-specified model is measured in each patient. The test score is on a scale of 0 to 1.0 and relates to the probability of disease.
Time frame: At study entry
The area under the ROC curve is used to determine the overall performance of the model at the completion of the study. An area over 0.7 is considered clincially significant.
2 secondary outcomes
Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients
Time frame: At study entry
Housekeeping gene Ct values on PCR analysis will be measured in individual patients
Time frame: At study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Jack L Martin, MD principal investigator
San Antonio Endovascular and Heart Institute
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 Pre-diabetes and Type II Diabetes, run by PeriRx 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. 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?
Results are not available in the source record.
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?
A multi marker test score based on a pre-specified model is measured in each patient. The test score is on a scale of 0 to 1.0 and relates to the probability of disease. (time frame: At study entry). 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 12 Apr 2018.