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CTRI Number  CTRI/2024/07/070058 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Estimation of Apelin and Fibroblast growth factor-21 (FGF-21) in periodontal disease and Diabetes patients 
Scientific Title of Study   Estimation of Apelin and Fibroblast growth factor 21 (FGF21) 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  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  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  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  10th milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 
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 The Oxford Dental College  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 Apelin and FGF-21 in periodontitis and T2DM patients.
Explore any correlation of Apelin with FGF-21 and clinical parameters. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Explore any correlation of Apelin with FGF-21 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)   14/08/2024 
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  
Periodontitis (PD) is a chronic inflammatory disorder mediated by host and bacterial interactions and manifested by damage to the periodontal tissues which may progress to tooth loss. The pathogenesis of periodontitis involves the interaction between periodontal pathogens and host inflammatory and immune responses. Diabetes mellitus (DM) is a cluster of metabolic disorders that are chiefly characterized by hyperglycaemia due to impaired secretion or action of insulin, or both. Several mechanisms have been proposed to explain the biological link between DM and periodontal diseases including the formation of advanced glycation end products (AGEs), changes in collagen metabolism and immune function, and increased oxidative stress.

Apelin (APLN) is a adipocytokine that is encoded by the APLN gene and exerts its functions through autocrine and paracrine pathways by binding to endogenous ligand of the G-protein coupled receptor. It is expressed in various organs & in most cell types including myocytes, smooth muscle cells and fibroblasts. It has been proposed that high apelin levels in people with type 2 diabetes mellitus (T2DM) might be a compensatory mechanism for decreased insulin sensitivity. In reduced levels or absence of insulin, apelin is secreted. This, in turn, decreases the glucose level by increasing the glucose uptake in vital tissues such as skeletal muscle and adipose tissue. Hence, higher levels of apelin are reported in patients with T2DM. Apelin is also released by many cell types in the oral cavity in response to bacterial activity. Periodontitis has been suggested to contribute to adipose tissue inflammation by promoting insulin resistance and insulin-induced apelin expression has been demonstrated in adipocytes.

Fibroblast growth factor 21 (FGF21) is a small molecular weight polypeptide of FGF hormone which is mainly produced in liver and expressed in extrahepatic tissues such as adipose tissue and skeletal muscle. FGF21 plays a crucial role in maintaining tissue homeostasis of both glucose and lipid metabolism and responding to various stressful stimuli, such as inflammation, oxidative stress and hypoxia. The elevation of circulating FGF21 has been closely associated with metabolic disorders including diabetes and is responsible for various actions in energy metabolism and injury protection as a hepatokine, adipokine and myokine in an endocrine or autocrine/paracrine manner, leading to cellular stress resistance and activation of anti-oxidation and inflammation reduction mechanisms.

A state of systemic inflammation induced by periodontitis is a major key linking periodontitis to several diseases such as T2DM. FGF21 and Apelin are protein molecules that potentially involve the inflammatory and immunity response which is a fundamental process in the pathogenesis of diabetes and periodontitis. Therefore, FGF21 and Apelin might be potential biomarkers for linking diabetes to periodontitis.
To the best of our knowledge there are no studies investigating the relationship between Apelin and FGF-21 in periodontal disease and T2DM. Hence, the aim of this study is to comparatively evaluate salivary and serum levels of Apelin and FGF-21 in generalized periodontitis and T2DM.
 
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