Type 2 DiabetesNCT06327503
Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM
An observational study of Type 2 Diabetes, run by University of Belgrade at 1 site in Serbia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- saliva samples collecting
- How many people
- 24 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Apr 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients with maxillary and mandibular total edentulism with and without T2DM
- for patients with T2DM - presence of controlled T2DM
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- saliva samples collecting
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva samples collectingOther
non-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container
| Study group | Role | What they receive |
|---|---|---|
| T2DM patients | patients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications Receives: Other: saliva samples collecting | |
| non-T2DM patients | age and general health matched control group without Type 2 Diabetes Mellitus Receives: Other: saliva samples collecting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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,
Measured: 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,
Measured: 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,
Measured: 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,
Measured: on 5th day after sample collection
opiorphin levels in saliva
levels of opiorphin in saliva samples obtained from T2DM and non-T2DM groups,
Measured: on 5th day after sample collection
Secondary outcomes (1)
unstimulated saliva flow
measuring of the flow of unstimulated saliva by dividing the volume of saliva with the time necessary for the sample collection
Measured: immediately after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija S. Milic, University of Belgrade
- Investigators
- Marija S Milic, DDS PhD, Principal investigator, University of Belgrade School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327503
- Sponsor's protocol ID
- 36/7-2024
- Status last verified
- Jul 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Signal Molecules Relevant for Neural and Vascular Homeostasis in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06327503
- Acronym / sponsor ID
- 36/7-2024
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM patients | – | Other: saliva samples collectingpatients with diagnosed controlled Type 2 Diabetes Mellitus with or without systemic complications |
| non-T2DM patients | – | Other: saliva samples collectingage and general health matched control group without Type 2 Diabetes Mellitus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients with maxillary and mandibular total edentulism with and without T2DM
- for patients with T2DM - presence of controlled T2DM
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva samples collectingnon-invasive collection of unstimulated whole saliva by spitting method into sterile plastic container | Other | T2DM patients, non-T2DM patients |
Primary outcome
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
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
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,
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,
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,
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,
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,
1 secondary outcome
unstimulated saliva flow
Time frame: immediately after sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marija S Milic, DDS PhD principal investigator
University of Belgrade School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGF levels in saliva (time frame: on 5th day after sample collection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.