Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM
Salivary Signal Molecules Relevant for Neural and Vascular Homeostasis in Patients With Type 2 Diabetes Mellitus
1 other identifier
observational
24
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Apr 2024
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 25, 2024
July 1, 2024
3 months
March 18, 2024
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
opiorphin levels in saliva
levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups,
on 5th day after sample collection
Secondary Outcomes (1)
unstimulated saliva flow
immediately after sample collection
Study Arms (2)
T2DM patients
patients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications
non-T2DM patients
age and general health matched control group without Type 2 Diabetes Mellitus
Interventions
non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container
Eligibility Criteria
Study population will comprise age and general health matched groups with and without T2DM, with total edentulism in the upper and lower jaw
You may qualify if:
- patients with maxillary and mandibular total edentulism with and without T2DM
- for patients with T2DM - presence of controlled T2DM
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Belgrade School of Dental Medicine
Belgrade, 11000, Serbia
Biospecimen
Samples of unstimulated whole saliva kept on -80 Celsius degrees until laboratory analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marija S Milic, DDS PhD
University of Belgrade School of Dental Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 25, 2024
Study Start
April 1, 2024
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP