Salivary Transcriptome Biomarkers for Early Diabetes Detection
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|