Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM

Type 2 Diabetes Clinical Trial

Official title:

Salivary Signal Molecules Relevant for Neural and Vascular Homeostasis in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327503
• Other study ID #: 36/7-2024
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Belgrade
• Contact: Marija S Milic, DDS Ph. D
• Phone: +381112646280
• Email: marija.milic[@]stomf.bg.ac.rs
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• saliva samples collecting
non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container

Locations

Country	Name	City	State
Serbia	University of Belgrade School of Dental Medicine	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	opiorphin levels in saliva	levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups,	on 5th day after sample collection
Secondary	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