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

Completed

• Conditions: Oral Lichen Planus; Diabetes Mellitus
• Interventions: Genetic: comparative semiquantitative immunohistochemistry

• Registration Number: NCT03257228
• Lead Sponsor: University of Zagreb

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-11-01
• Study Completion: 2015-11-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• non-consent patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oral lichen planus and diabetes mellitus	comparative semiquantitative immunohistochemistry	Histopathologically confirmed samples of oral lichen planus underwent immunohistochemical analysis of IGF1 and IGF2 expression. Blood glucose level was determined one day before taking biopsy.
oral lichen planus	comparative semiquantitative immunohistochemistry	Histopathologically confirmed samples of oral lichen planus underwent immunohistochemical analysis of IGF1 and IGF2 expression. Blood glucose level was determined one day before taking biopsy.
healthy mucosa	comparative semiquantitative immunohistochemistry	Samples of healthy mucosa underwent immunohistochemical analysis of IGF1 and IGF2 expression. Blood glucose level was determined one day before taking mucosa samples.

Primary Outcome Measures

Name	Time	Method
Insulin like growth factors in patients with OLP and diabetes mellitus	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