Salivary inflammatory biomarkers associated with glycemic control and oral health
Inventors
Alman, Amy Christine • Burkhardt, Brant Roger
Assignees
University of South Florida • University of South Florida St Petersburg
Publication Number
US-9753041-B2
Publication Date
2017-09-05
Expiration Date
2035-04-21
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Abstract
The present invention provides non-invasive diagnostic methods and kits for determining and/or monitoring oral health and glycemic control in subjects with Type 1 diabetes.
Core Innovation
The invention provides non-invasive diagnostic methods and kits for determining and/or monitoring oral health and glycemic control in subjects with Type 1 diabetes. A saliva sample is obtained from a subject, and the level of one or more cytokines and/or matrix metalloproteinases (MMPs) is measured in the sample. These levels are then compared to a reference value, where an elevated level indicates decreased glycemic control, decreased oral health, and/or progression of diabetes.
The invention addresses the problem that traditional biomarker studies in diabetes rely primarily on serum, which is difficult and costly to obtain and analyze. There is a bi-directional relationship between diabetes and periodontal disease, and the presence of inflammatory mediators in saliva—such as cytokines and MMPs—has not been thoroughly studied in Type 1 diabetes, especially in relation to glycemic control. This creates a need for non-invasive, easily accessible diagnostic tools that can monitor both periodontal and metabolic health.
The methods and kits defined in this invention utilize the detection of specific biomarkers, including IL-1β, IL-6, IL-8, IL-10, TNF-α, IFN-γ, MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, and MMP-10 in saliva, to determine health status. Distinct biomarker profiles are able to distinguish between levels of glycemic control and oral health, supporting enhanced disease management and serving as a foundation for further development of rapid, economical screening tools for diabetes using saliva.
Claims Coverage
The patent includes one independent claim that defines the main inventive feature for the determination of specific biomarker levels in saliva samples of Type I diabetes subjects.
Method for determining levels of TNF-α, IL-1β, MMP-8, and MMP-9 in saliva from Type I diabetes subjects
This inventive feature covers a method comprising: 1. Obtaining a saliva sample from a subject having Type I diabetes. 2. Contacting the saliva sample with binding partners that specifically bind to the biomarkers TNF-α, IL-1β, MMP-8, and MMP-9, forming complexes. 3. Detecting the formation of the complexes using a system that generates quantifiable signals. 4. Determining the levels of each biomarker based on the quantifiable signals. The focus is specifically on these four biomarkers within a saliva sample from a Type I diabetes subject and the steps that reliably measure their individual concentrations.
The inventive feature centers on a specific, quantifiable method for assessing multiple key inflammatory biomarkers from saliva samples, specifically tailored to monitoring subjects with Type I diabetes.
Stated Advantages
The invention enables non-invasive, easily accessible, and economical diagnostic assessment compared to serum-based methods.
Saliva collection has high patient compliance and can be performed by minimally trained personnel with minimal processing.
The methods and kits allow for monitoring and distinguishing glycemic control and oral health in Type 1 diabetes subjects, supporting enhanced clinical management.
Documented Applications
Monitoring and/or determining glycemic control, diabetes progression, and/or oral health in subjects with Type 1 diabetes.
Development and use of kits for non-invasive assessment of oral health and glycemic status in clinical or potentially home settings.
Application as a diagnostic tool in routine dental examinations or physician visits to enable compliance and rapid assessment.
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