| CTRI Number |
CTRI/2024/07/069992 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Levels of Adropin and Irisin in periodontal disease and Diabetes |
|
Scientific Title of Study
|
Estimation of Adropin and Irisin levels in saliva and serum in generalized periodontitis patients with and without Type 2 Diabetes mellitus (T2DM) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathi S Kumar |
| Designation |
Post graduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room No. 3, The Oxford Dental College, 10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka
Bangalore KARNATAKA 560068 India |
| Phone |
9148240799 |
| Fax |
|
| Email |
skumarswathi1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashish S Nichani |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College, 10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka
Bangalore KARNATAKA 560068 India |
| Phone |
9845252203 |
| Fax |
|
| Email |
nichaniashish@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swathi S Kumar |
| Designation |
Post graduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room No.3, The Oxford Dental College, 10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka
Bangalore KARNATAKA 560068 India |
| Phone |
9148240799 |
| Fax |
|
| Email |
skumarswathi1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Department of Periodontology, room number-03, 10th milestone, Bommanahalli, Hosur road, Bangalore- 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Swathi S Kumar |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College, 10th milestone, Hosur Rd, Bommanahalli, Bengaluru - 560095, Karnataka. India |
| Type of Sponsor |
Other [(Self funded)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swathi S Kumar |
The Oxford Dental College |
Department of periodontology, 2nd floor, room number-03. Bangalore KARNATAKA
Bangalore KARNATAKA |
9148240799
skumarswathi1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have not received any periodontal treatment in
previous six months.
2. Patients diagnosed with T2DM as per
American Diabetes Association criteria (2019).
3. Patients with a diagnosis of Generalized Periodontitis as per World Workshop Classification criteria (2017). |
|
| ExclusionCriteria |
| Details |
1. Smokers and alcoholics.
2. Patients with systemic diseases like hypertension, cardiovascular
diseases, rheumatoid arthritis, tumours, autoimmune diseases and
renal diseases.
3. Pregnant, lactating females and post menopausal women.
4. Any other systemic disease which can alter the course of
periodontal disease.
5. Patients on any medication like anti-inflammatory drugs,
antibiotics and anti-epileptic drugs in the past 6 months. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparatively evaluate salivary and serum levels of Adropin and Irisin in periodontitis and T2DM patients.
Explore any correlation of Adropin and Irisin and clinical parameters. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Explore any correlation of Adropin with irisin and clinical, biochemical & demographic parameters. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus is a disease associated with a series of symptoms and etiologies ranging from a cell-mediated autoimmune disease to a non-autoimmune metabolic disorder. Insulin secretion can be inhibited by proinflammatory cytokines causing dysregulation of beta cells and ultimately to Type 2 Diabetes mellitus (T2DM). Periodontitis can contribute to adipose tissue inflammation and subsequent systemic insulin resistance. Periodontitis and T2DM have common mechanisms that are associated with altered immune-inflammatory responses at local and systemic levels. Adropin is a multifunctional peptide, which, being primarily secreted by the liver and brain, modulates the metabolic homeostasis of the heart, vasculature, kidney, and skeletal muscles in connection with nutrition status. Adropin exerts its biological effects through binding with three distinct membrane receptors, which seem to be responsible for various modulations of target tissue metabolism. The favourable effects of adropin on vascular structure and function are mediated by vascular endothelial growth factor (VEGF) via binding with VEGF receptor 2 (VEGFR2). Periodontal lesions are associated with activation of pathological angiogenesis and a high number of newly formed blood vessels. The gingival epithelium activates the angiogenic chain reaction in the connective compartment through VEGFR2 via VEGF secretion. Adropin activates the glucose transporter 4 receptor through its Akt phosphorylation and improves glucose metabolism. It also inhibits inflammation by suppressing the production of several pro-inflammatory cytokines (tumour necrosis factor alpha, C-reactive protein, and interleukin-6). However, the clinical significance of adropin levels in different patient populations remains unclear. Irisin a novel myokine discovered in 2012, is a secreted peptide that is C-terminally cleaved from fibronectin type III domain-containing protein 5 (FNDC5) in the skeletal muscles and released into the bloodstream. Lack of physical exercise, obesity, and insulin resistance (IR) have been consistently considered as high-risk factors for T2DM. It is released by skeletal muscles during physical exercise. Circulating irisin levels are negatively associated with IR. Irisin modulates the inflammatory response in pathologies which are associated with constant chronic inflammation such as Type 2 diabetes mellitus (T2DM) and periodontitis. Although there is evidence suggesting the role of irisin in promoting osteogenic differentiation and matrix secretion of Periodontal ligament cells (PDLCs) cultured in vitro, little is known about the effects of irisin on inflamed periodontal tissues, including the alveolar bone and local host cells under diabetic conditions. To the best of our knowledge there are no studies investigating the relationship between Adropin and Irisin levels in periodontal disease and T2DM. Hence, the aim of this study is to comparatively evaluate salivary and serum levels of Adropin and Irisin levels in generalized periodontitis and T2DM. |