Salivary Transcriptome Biomarkers for Early Diabetes Detection

NCT ID: NCT02673762

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-02-28

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.

Conditions

Pre-diabetes; Type II Diabetes; Insulin Resistance

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal glucose metabolism

Normal fasting blood glucose, 2 hour post prandial glucose, hemoglobin A1c and HOMA IR

No interventions assigned to this group

Pre-diabetes

Abnormal glucose tolerance tests and/or insulin resistance with fating blood glucose and hemoglobin A1c below type II diabetes levels

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PeriRx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack L Martin, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio Endovascular and Heart Institute

Locations

San Antonio Endovascular and Heart Institute

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PeriRx003

Identifier Type: -

Identifier Source: org_study_id