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Salivary Transcriptome Biomarkers for Early Diabetes Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Pre-diabetes Type II Diabetes Insulin Resistance

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Salivary mRNA and cDNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with undiagnosed abnormal glucose metabolism undergoing clinically driven screening for pre-diabetes and type II diabetes.
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

Information from the National Library of Medicine

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


Locations
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United States, Texas
San Antonio Endovascular and Heart Institute
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
PeriRx
Investigators
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Principal Investigator: Jack L Martin, MD San Antonio Endovascular and Heart Institute
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Responsible Party: PeriRx
ClinicalTrials.gov Identifier: NCT02673762    
Other Study ID Numbers: PeriRx003
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism