Salivary Transcriptome Biomarkers for Early Diabetes Detection

• Conditions: Insulin Resistance; Pre-diabetes; Type II Diabetes

• Registration Number: NCT02673762
• Lead Sponsor: PeriRx

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.

Study Timeline

• Study First Submitted: 2015-12-19
• Study Start: 2016-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients	At study entry	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.
Housekeeping gene Ct values on PCR analysis will be measured in individual patients	At study entry	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.

Trial Locations

Locations (1)

San Antonio Endovascular and Heart Institute; 🇺🇸 San Antonio, Texas, United States