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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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