Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257228
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2017-08-18
Brief Title:
The Association Between Diabetes Mellitus Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 IGF1 and IGF2
Sponsor:
University of Zagreb
Organization:
University of Zagreb
Study Overview
Official Title:
The Association Between Diabetes Mellitus Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 IGF1 and IGF2
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None