Oral Lichen PlanusNCT03257228
The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)
An observational study of Oral Lichen Planus and Diabetes Mellitus, run by University of Zagreb.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Oral Lichen Planus, Diabetes Mellitus
- What is being tested?
- comparative semiquantitative immunohistochemistry
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Adult, Older adult
Study population: The patients included in the study are patients with oral lichen ruber referred to the Department of Oral Medicine, University of Zagreb. Healthy mucosa samples were taken from healthy volunteers referred for alveotomy of wisdom tooth to the Department of Oral Surgery, School of Dental Medicine, University of Zagreb.
Who may be able to join
- histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus
- healthy volunteers referred for alveolotomy
Who cannot join
- non-consent patients
About this study
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.
Read the 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.
- Conditions
- Oral Lichen Planus, Diabetes Mellitus
- Being tested
- comparative semiquantitative immunohistochemistry
- Medical subject headings
- Lichen Planus, Oral, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative semiquantitative immunohistochemistryGenetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: comparative semiquantitative immunohistochemistry | |
| 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. Receives: Genetic: comparative semiquantitative immunohistochemistry | |
| 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. Receives: Genetic: comparative semiquantitative immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2014-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Nov 2014
- Primary completion1 Nov 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257228
- Sponsor's protocol ID
- BM 1.62
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23207292Cohen 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.
PubMed 22593429Sarfstein 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.
PubMed 23620761
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)
- ClinicalTrials.gov ID
- NCT03257228
- Acronym / sponsor ID
- BM 1.62
- Conditions
- Oral Lichen Planus, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral lichen planus and diabetes mellitus | – | Genetic: comparative semiquantitative immunohistochemistryHistopathologically 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 | – | Genetic: comparative semiquantitative immunohistochemistryHistopathologically 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 | – | Genetic: comparative semiquantitative immunohistochemistrySamples of healthy mucosa underwent immunohistochemical analysis of IGF1 and IGF2 expression. Blood glucose level was determined one day before taking mucosa samples. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study are patients with oral lichen ruber referred to the Department of Oral Medicine, University of Zagreb. Healthy mucosa samples were taken from healthy volunteers referred for alveotomy of wisdom tooth to the Department of Oral Surgery, School of Dental Medicine, University of Zagreb.
Key inclusion criteria (2 listed)
- histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus
- healthy volunteers referred for alveolotomy
Key exclusion criteria (1 listed)
- non-consent patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparative semiquantitative immunohistochemistry | Genetic | healthy mucosa, oral lichen planus, oral lichen planus and diabetes mellitus |
Primary outcome
Insulin like growth factors in patients with OLP and diabetes mellitus
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Background: PubMed 23207292Djiogue 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.
- Background: PubMed 22593429Cohen 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.
- Background: PubMed 23620761Sarfstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Diabetes Mellitus, run by University of Zagreb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin like growth factors in patients with OLP and diabetes mellitus (time frame: 2014-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257228, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.