Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
OTHERsaliva samples collecting
non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container
Sponsors
University of Belgrade
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with maxillary and mandibular total edentulism with and without T2DM * for patients with T2DM - presence of controlled T2DM
Exclusion criteria
* presence of the acute pain or swelling in orofacial region * antibiotic therapy up to three weeks prior to study start * conditions or diseases that affect the function of salivary glands (e.g. Sjogren syndrome) * radiotherapy of the orofacial region * tobacco smokers * alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opiorphin levels in saliva | on 5th day after sample collection | levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups, |
| NGF levels in saliva | on 5th day after sample collection | levels of nerve growth factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method |
| GDNF levels in saliva | on 5th day after sample collection | levels of glial-cells derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method |
| BDNF levels in saliva | on 5th day after sample collection | levels of brain derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups, |
| s-Klotho levels in saliva | on 5th day after sample collection | levels of soluble alpha-klotho in saliva samples obtained from T2DM and non-T2DM groups, |
| VEGF levels in saliva | on 5th day after sample collection | levels of vascular endothelial growth factor in saliva samples obtained from T2DM and non-T2DM groups, |
| IL-6 levels in saliva | on 5th day after sample collection | levels of interleukin-6 in saliva samples obtained from T2DM and non-T2DM groups, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| unstimulated saliva flow | immediately after sample collection | measuring of the flow of unstimulated saliva by dividing the volume of saliva with the time necessary for the sample collection |
Countries
Serbia
Outcome results
None listed