Clinical trial NCT02673762: Salivary Transcriptome Biomarkers for Early Diabetes Detection
Official title: Salivary Transcriptome Biomarkers for Early Diabetes Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-diabetes
Type II Diabetes
Insulin Resistance
Lead sponsor: PeriRx
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with undiagnosed abnormal glucose metabolism undergoing clinically driven screening for pre-diabetes and type II diabetes.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with unknown glucose metabolism status and
* Requiring clinically driven screening for abnormal glucose metabolism and
* Outpatient status

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: At study entry
Secondary outcomes:
measure: Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients
timeFrame: At study entry
measure: Housekeeping gene Ct values on PCR analysis will be measured in individual patients
timeFrame: At study entry
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Endovascular and Heart Institute
state: Texas
Study officials:
affiliation: San Antonio Endovascular and Heart Institute
name: Jack L Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: