Clinical trial NCT06327503: Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM
Official title: Salivary Signal Molecules Relevant for Neural and Vascular Homeostasis in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will comprise age and general health matched groups with and without T2DM, with total edentulism in the upper and lower jaw

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.


Eligibility criteria: 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

Primary outcomes:
measure: NGF levels in saliva
timeFrame: on 5th day after sample collection
measure: GDNF levels in saliva
timeFrame: on 5th day after sample collection
measure: BDNF levels in saliva
timeFrame: on 5th day after sample collection
measure: s-Klotho levels in saliva
timeFrame: on 5th day after sample collection
measure: VEGF levels in saliva
timeFrame: on 5th day after sample collection
measure: IL-6 levels in saliva
timeFrame: on 5th day after sample collection
measure: opiorphin levels in saliva
timeFrame: on 5th day after sample collection
Secondary outcomes:
measure: unstimulated saliva flow
timeFrame: immediately after sample collection
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: University of Belgrade School of Dental Medicine
Study officials:
affiliation: University of Belgrade School of Dental Medicine
name: Marija S Milic, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References: