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Various signal molecules are detected in blood and tissues of patients with T2DM, that are important for the function of neural tissue in diabetic setting. Among them, specifically important are neuroprotective and neurotrophic growth factors such as nerve growth factor (NGF), glial cells - derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF). Furthermore, several other signal molecules are discovered to affect vascular tissues homeostasis in T2DM, including soluble alpha-klotho (s-Klotho), vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6). Most of these molecules are also detected in saliva in various states and diseases of orofacial system, but data about their levels in saliva of T2DM patients are lacking, although neural and vascular diabetic complications are present in orofacial tissues and organs. Also, there is no data about presence and levels of s-Klotho in saliva of healthy or T2DM patients, although it was reported that this molecule exerts protective effect on the salivary glands tissue. Salivary opiorphin is recently discovered pentapeptide, primarily isolated from saliva. It acts as an inhibitor of the enzymes that perform degradation of endogenous antinociceptive molecules enkephalins, affecting nociceptive signal transduction. This may be of special importance since some intraoral complications of T2DM (e.g. burning mouth) may have underlying peripheral neural changes as a pathophysiological mechanism. Against this background, the aim of the study is to detect the presence and levels of mentioned signal molecules in saliva of patients with and without T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM patients | patients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications |
| |
| non-T2DM patients | age and general health matched control group without Type 2 Diabetes Mellitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saliva samples collecting | Other | non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container |
|
| Measure | Description | Time Frame |
|---|---|---|
| NGF levels in saliva | levels of nerve growth factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method | on 5th day after sample collection |
| GDNF levels in saliva | levels of glial-cells derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method | on 5th day after sample collection |
| BDNF levels in saliva | levels of brain derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups, | on 5th day after sample collection |
| s-Klotho levels in saliva | levels of soluble alpha-klotho in saliva samples obtained from T2DM and non-T2DM groups, | on 5th day after sample collection |
| VEGF levels in saliva | levels of vascular endothelial growth factor in saliva samples obtained from T2DM and non-T2DM groups, | on 5th day after sample collection |
| IL-6 levels in saliva | levels of interleukin-6 in saliva samples obtained from T2DM and non-T2DM groups, | on 5th day after sample collection |
| opiorphin levels in saliva | levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups, | on 5th day after sample collection |
| Measure | Description | Time Frame |
|---|---|---|
| unstimulated saliva flow | measuring of the flow of unstimulated saliva by dividing the volume of saliva with the time necessary for the sample collection | immediately after sample collection |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will comprise age and general health matched groups with and without T2DM, with total edentulism in the upper and lower jaw
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| Name | Affiliation | Role |
|---|---|---|
| Marija S Milic, DDS PhD | University of Belgrade School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Belgrade School of Dental Medicine | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Samples of unstimulated whole saliva kept on -80 Celsius degrees until laboratory analysis
| D004700 | Endocrine System Diseases |