Salivary Transcriptome Biomarkers for Early Diabetes Detection
|ClinicalTrials.gov Identifier: NCT02673762|
Recruitment Status : Unknown
Verified April 2018 by PeriRx.
Recruitment status was: Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : April 12, 2018
|Condition or disease|
|Pre-diabetes Type II Diabetes Insulin Resistance|
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||Salivary Transcriptome Biomarkers for Early Diabetes Detection|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Normal glucose metabolism
Normal fasting blood glucose, 2 hour post prandial glucose, hemoglobin A1c and HOMA IR
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
- 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.
- Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients [ Time Frame: 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 [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673762
|United States, Texas|
|San Antonio Endovascular and Heart Institute|
|San Antonio, Texas, United States, 78258|
|Principal Investigator:||Jack L Martin, MD||San Antonio Endovascular and Heart Institute|