Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM

University of Belgrade

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: saliva samples collecting

Study type: Observational

Funder types: Other

Identifiers

NCT06327503

36/7-2024

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

T2DM patients

Description:

patients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications

Treatment:

Other: saliva samples collecting

non-T2DM patients

Description:

age and general health matched control group without Type 2 Diabetes Mellitus

Treatment:

Other: saliva samples collecting