NCT06327503Completed
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
Source: ClinicalTrials.gov · Last updated 25 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 18 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- University of Belgrade
- Diseases
- Type 2 diabetes
- NCT number
- NCT06327503
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From 1 Apr 2024 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- antibiotic therapy up to three weeks prior to study start
- radiotherapy of the orofacial region
- alcohol and/or drug abuse
Other illness
- conditions or diseases that affect the function of salivary glands (e.g. Sjogren syndrome)
Other
- presence of the acute pain or swelling in orofacial region
- tobacco smokers
Who the study is looking for
- patients with maxillary and mandibular total edentulism with and without T2DM
- for patients with T2DM - presence of controlled T2DM
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Belgrade School of Dental Medicine Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.