Skip to main content
OpenTrials
Completed

NCT Number: NCT06327503

Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Belgrade School of Dental Medicine

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva samples collecting

Other

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

Primary outcomes

  1. NGF levels in saliva

    Time frame: on 5th day after sample collection

    levels of nerve growth factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method

  2. GDNF levels in saliva

    Time frame: on 5th day after sample collection

    levels of glial-cells derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups, detected by means of ELISA method

  3. BDNF levels in saliva

    Time frame: on 5th day after sample collection

    levels of brain derived neurotrophic factor in saliva samples obtained from T2DM and non-T2DM groups,

  4. s-Klotho levels in saliva

    Time frame: on 5th day after sample collection

    levels of soluble alpha-klotho in saliva samples obtained from T2DM and non-T2DM groups,

  5. VEGF levels in saliva

    Time frame: on 5th day after sample collection

    levels of vascular endothelial growth factor in saliva samples obtained from T2DM and non-T2DM groups,

  6. IL-6 levels in saliva

    Time frame: on 5th day after sample collection

    levels of interleukin-6 in saliva samples obtained from T2DM and non-T2DM groups,

  7. opiorphin levels in saliva

    Time frame: on 5th day after sample collection

    levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups,

Secondary outcomes

  1. unstimulated saliva flow

    Time frame: immediately after sample collection

    measuring of the flow of unstimulated saliva by dividing the volume of saliva with the time necessary for the sample collection

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.