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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257228
• Other study ID #: BM 1.62
• Status: Completed
• Phase: N/A
• First received: August 18, 2017
• Last updated: August 29, 2017
• Start date: November 1, 2014
• Est. completion date: November 1, 2015

Study information

• Verified date: August 2017
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus

• healthy volunteers referred for alveolotomy

Exclusion Criteria:

• non-consent patients

Related Conditions & MeSH terms

• Diabetes Mellitus
• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Genetic:
• comparative semiquantitative immunohistochemistry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

References & Publications (3)

Cohen DH, LeRoith D. Obesity, type 2 diabetes, and cancer: the insulin and IGF connection. Endocr Relat Cancer. 2012 Sep 5;19(5):F27-45. doi: 10.1530/ERC-11-0374. Print 2012 Oct. Review. — View Citation

Djiogue S, Nwabo Kamdje AH, Vecchio L, Kipanyula MJ, Farahna M, Aldebasi Y, Seke Etet PF. Insulin resistance and cancer: the role of insulin and IGFs. Endocr Relat Cancer. 2013 Jan 7;20(1):R1-R17. doi: 10.1530/ERC-12-0324. Print 2013 Feb. Review. — View Citation

Sarfstein R, Friedman Y, Attias-Geva Z, Fishman A, Bruchim I, Werner H. Metformin downregulates the insulin/IGF-I signaling pathway and inhibits different uterine serous carcinoma (USC) cells proliferation and migration in p53-dependent or -independent manners. PLoS One. 2013 Apr 19;8(4):e61537. doi: 10.1371/journal.pone.0061537. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin like growth factors in patients with OLP and diabetes mellitus	Evaluation of the Insulin-like growth factor 1 and 2 (IGF1 and IGF 2) in patients with oral lichen planus and diabetes mellitus	2014-2015