Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM

May 6, 2024 updated by: Marija S. Milic, University of Belgrade

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University of Belgrade School of Dental Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2DM patients
patients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications
Other: saliva samples collecting
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
Other: saliva samples collecting
non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on 5th day after sample collection
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
on 5th day after sample collection
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,
on 5th day after sample collection
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,
on 5th day after sample collection
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,
on 5th day after sample collection
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,
on 5th day after sample collection
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,
on 5th day after sample collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately after sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Marija S Milic, DDS PhD, University of Belgrade School of Dental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36/7-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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