NON-INVASIVE SALIVARY ASSESSMENT OF PREDIABETES AND DIABETES

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DESCRIPTION (provided by applicant): The twin epidemics of obesity and diabetes threaten to overwhelm healthcare systems in the U.S. and worldwide, with almost 29 million Americans currently having frank diabetes (predominantly type-2; T2DM) and an additional 68 million with prediabetes. There is increasing evidence that periodontal disease and diabetes are related, and this connection is supported by our discovery of salivary biomarkers of diabetes. A major challenge in dealing with the burden of diabetes is our inability to easily and conveniently detect diabetes and prediabetes in at-risk populations due to the lack of a non-invasive, point-of-care test. The current standards for glucose homeostasis determination, i.e., oral glucose tolerance test or hemoglobin A1c, are expensive and requires hospital visits that are an issue for disadvantaged populations, contributing to the health disparities that plague diabetes testing, care, and prevention. The goal of the studies that comprise this Phase-I proposal is to validate novel salivary biomarkers of diabetes and prediabetes. Planned Phase-II studies will assess the performance of a subset of biomarkers and will incorporate optimized analytes into an efficient device design in order to develop a rapid, non-invasive, multi-analyte diagnostic test for accurate assessment of prediabetes or frank diabetes that is superior to existing glucose-based parameters. Successful development of salivary testing for diabetes will have a significant impact on the effective management of this critical public health crisis. The simplicity and non-invasive aspects of this approach will also be of benefit in the developing world. In addition to a potential direct impact on diabetes detection and monitoring, the introduction of salivary biomarkers for diabetes will greatly expand the scope of salivary diagnostics. While there has been intense interest in saliva as a diagnostic fluid, the practical application of saliva to human disease to date has been limited to a few examples such as testing for HIV and drugs of abuse. We believe that the successful development of salivary diabetes testing as proposed in this application will increase the appreciation of the advantages of saliva as a diagnostic fluid and encourage the expansion of its use in clinical diagnostics. PUBLIC HEALTH RELEVANCE: The incidence of diabetes is reaching epidemic proportions in the US and the world at large, with projected massive increases in the number of individuals with additional serious complications such as heart, kidney, and eye disease and cognitive decline. Diabetes and periodontal disease are both chronic inflammatory illnesses, and there is a growing consensus that these two disorders are interrelated. Specifically, diabetes is a risk factor for severe gingivitis and periodontitis, and periodontitis is a risk factor for poor glycemic control and, possibly, diabetic complications. A significant problem is the lack of a simple, inexpensive, and convenient approach to detect persons with diabetes or prediabetes to direct them to suitable treatments to prevent or delay development of more serious disease. Based upon the evidence that oral disease and diabetes are related, we have previously discovered proteins in saliva that correlate with diabetes. This project will determine the ability of these salivary proteins to accurately predict the presence of diabetes and prediabetes in a clinical validation study, and will provide the foundation for incorporation of a set of these proteins into a simple non-invasive test device that will be suitable for medical office, home, and field use.