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Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM - Trial NCT06327503

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NCT06327503
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Trial Details
ClinicalTrials.gov โ€ข NCT06327503
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Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM
Salivary Signal Molecules Relevant for Neural and Vascular Homeostasis in Patients With Type 2 Diabetes Mellitus

Study Focus

Type 2 Diabetes

saliva samples collecting

Observational

other

Sponsor & Location

University of Belgrade

Belgrade, Serbia

Timeline & Enrollment

N/A

Apr 01, 2024

Jun 30, 2024

30 participants

Primary Outcome

NGF levels in saliva,GDNF levels in saliva,BDNF levels in saliva,s-Klotho levels in saliva,VEGF levels in saliva,IL-6 levels in saliva,opiorphin levels in saliva

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.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06327503

Non-Device Trial