Salivary Transcriptome Biomarkers for Early Diabetes Detection

NCT02673762 | Unknown

• 1 other identifier: PeriRx003
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes; Type II Diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (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.

  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.

  At study entry

Secondary Outcomes (2)

• Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients

  At study entry

• Housekeeping gene Ct values on PCR analysis will be measured in individual patients

  At study entry

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with undiagnosed abnormal glucose metabolism undergoing clinically driven screening for pre-diabetes and type II diabetes.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• PeriRx: lead

Study Sites (1)

San Antonio Endovascular and Heart Institute

San Antonio, Texas, 78258, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Salivary mRNA and cDNA

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Jack L Martin, MD

  San Antonio Endovascular and Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: February 4, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)