Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM

NCT ID: NCT06327503

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-06-30

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

T2DM patients

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

saliva samples collecting

Intervention Type: OTHER

non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container

non-T2DM patients

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

saliva samples collecting

Intervention Type: OTHER

non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container

Interventions

saliva samples collecting

non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Marija S. Milic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marija S Milic, DDS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Belgrade School of Dental Medicine

Locations

University of Belgrade School of Dental Medicine

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

36/7-2024

Identifier Type: -

Identifier Source: org_study_id