跳至主要内容
临床试验/NCT03257228
NCT03257228已完成不适用

The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)

University of Zagreb0 个研究点目标入组 24 人开始时间: 2014年11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
主要终点
Insulin like growth factors in patients with OLP and diabetes mellitus

研究概览

简要总结

Diabetes mellitus is among the most common chronic diseases, with significant and well documented impact on oral cavity health. Among the most common diseases of the oral cavity mucosa and complications in patients with impaired glucose metabolism and diabetes mellitus is oral lichen ruber (OLR), which according to World Health Organisation (WHO) is considered potentially malignant disorder. It was found that lichen ruber in diabetes mellitus has a much more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. Although OLR etiology is unknown, evidence suggests cell-mediated autoimmune pathogenesis. OLR epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (IGF-1 and IGF-2) metabolism. The hypothesis of our research is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.

详细描述

Oral lichen ruber (OLR) in the diabetes mellitus patients has more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. OLR epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like Growth Factors 1 and 2 (IGF-1 and IGF-2) metabolism. The role of insulin-like growth factors (IGFs) is of great importance in normal growth and cell development (cell proliferation, differentiation and apoptosis), and is involved in different aspects of cell transformation in malignant phenotype. A change in the expression of IGF1, IGF2 and IGF2R proteins is described in several types of malignant tumors including oral cancer. However, data on their role in the development of malignant lesions of the oral cavity are scarce, and the results are inconsistent. Our hypothesis is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus
  • healthy volunteers referred for alveolotomy

排除标准

  • non-consent patients

结局指标

主要结局

Insulin like growth factors in patients with OLP and diabetes mellitus

时间窗: 2014-2015

Evaluation of the Insulin-like growth factor 1 and 2 (IGF1 and IGF 2) in patients with oral lichen planus and diabetes mellitus

次要结局

未报告次要终点

研究者

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

Božana Lončar Brzak

Asisstant Professor

University of Zagreb

相似试验