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临床试验/NCT06327503
NCT06327503已完成不适用

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

University of Belgrade1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
IL-6 levels in saliva

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with maxillary and mandibular total edentulism with and without T2DM
  • for patients with T2DM - presence of controlled T2DM

排除标准

  • 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

结局指标

主要结局

IL-6 levels in saliva

时间窗: on 5th day after sample collection

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

NGF levels in saliva

时间窗: 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

opiorphin levels in saliva

时间窗: on 5th day after sample collection

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

BDNF levels in saliva

时间窗: 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

时间窗: 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

时间窗: on 5th day after sample collection

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

GDNF levels in saliva

时间窗: 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

次要结局

  • unstimulated saliva flow(immediately after sample collection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marija S. Milic

Assistant Professor

University of Belgrade

研究点 (1)

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