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

NCT ID: NCT03257228

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-01

Study Completion Date

2015-11-01

Brief Summary

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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

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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.

Conditions

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Oral Lichen Planus Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oral lichen planus and diabetes mellitus

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.

comparative semiquantitative immunohistochemistry

Intervention Type GENETIC

oral lichen planus

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.

comparative semiquantitative immunohistochemistry

Intervention Type GENETIC

healthy mucosa

Samples of healthy mucosa underwent immunohistochemical analysis of IGF1 and IGF2 expression. Blood glucose level was determined one day before taking mucosa samples.

comparative semiquantitative immunohistochemistry

Intervention Type GENETIC

Interventions

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comparative semiquantitative immunohistochemistry

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non-consent patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Božana Lončar Brzak

Asisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 23207292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22593429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23620761 (View on PubMed)

Other Identifiers

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BM 1.62

Identifier Type: -

Identifier Source: org_study_id