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CTRI Number  CTRI/2024/08/072736 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study on Coagulation and Platelet Parameters in Type 2 Diabetic patients at a Tertiary Care Hospital  
Scientific Title of Study   A Comparative Cross-Sectional Study on Coagulation and Platelet Parameters in Type 2 Diabetic Patients and Non-Diabetic Individuals at a Tertiary Care Hospital  
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 Parth Rajendragiri Goswami  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot  
Address  Room no 308, Department of Pathology, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9099097923  
Fax    
Email  goswamiparth42@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parth Rajendragiri Goswami  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot  
Address  Room no 308, Department of Pathology, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9099097923  
Fax    
Email  goswamiparth42@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Parth Rajendragiri Goswami  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot  
Address  Room no 308, Department of Pathology, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9099097923  
Fax    
Email  goswamiparth42@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RAJKOT, Village Khandheri, Tehsil -Paddhari, Rajkot - 360110  
 
Primary Sponsor  
Name  AIIMS RAJKOT  
Address  AIIMS RAJKOT, Village Khandheri, Tehsil -Paddhari, Rajkot - 360110  
Type of Sponsor  Government medical college 
 
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 
PARTH GOSWAMI   AIIMS RAJKOT Hospital   OPD and IPD Division Medicine department , AIIMS RAJKOT Hospital
Rajkot
GUJARAT 
9099097923

goswamiparth42@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RAJKOT   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL   NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  (1) Diagnosed Individual of type 2 diabetes of either sex presented to OPD or IPD of age group 18-65 years
(2) Healthy control individual without type 2 diabetes of either sex presented to OPD or IPD of age group 18-65 years
 
 
ExclusionCriteria 
Details  (1) Type 1 DM
(2) History of thromboembolism
(3) Individual on anti-platelet or anti coagulation therapy or on Oral contraceptive
(4) Inherited knowns case of coagulation disorder
(5) Pregnant women
(6) Undergone any operation in last few weeks
(7) Known chronic liver disease
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
All cause coagulation parameter   At 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
All cause platelet parameters   2 years  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   25/08/2024 
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="2"
Months="0"
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  

1.    A significant issue for global health is diabetes mellitus (DM). In the world, type 2 diabetes, which is characterized by insulin resistance, accounts for 90% of cases .With 80% of DM patients dying from thrombotic causes and 75% of these fatalities coming from cardiovascular problems, people with DM have a high risk of atherothrombotic events. The incidence and prevalence of DM are rapidly increasing, making it one of the most common and expensive chronic diseases in the world.

Due to its 2- to 4-fold increase in the risk of peripheral artery disease, coronary heart disease, and stroke, atherothrombosis is the primary cause of morbidity and mortality in diabetes.Eighty percent of patients with DM died from thrombotic complications, with cardiovascular problems accounting for 75 percent of these deaths. Endothelial dysfunction, platelet hyperactivation, reactive oxygen species cause endothelial dysfunction, and enhanced activation of pro-thrombotic coagulation factors along with reduced fibrinolysis are the pathophysiological mechanisms linked to the diabetic pro-thrombotic state.

Diabetes involves various factors such as hyperglycemia, insulin resistance, insulin insufficiency, cellular abnormalities, metabolic problem, inflammation, and oxidative stress. These factors contribute to the dysregulation of multiple signaling pathways, which in turn stimulate platelet increased adhesion, activation, and aggregation. Research has demonstrated that the presence of hyperglycemia leads to an increase in platelet size and hyperactivation. Consequently, platelets of greater size exhibit a heightened release of prothrombotic substances, including thromboxane A2.

Hematological indicators that provide information on the coagulation status include fibrinogen, prothrombin time, and activated partial thromboplastin time. Relevant indicators that might indicate the quantity, size, and activity of platelets include platelet count and platelet indices . Therefore, the purpose of this study is to evaluate the platelet parameter and coagulation status of type II diabetic patients.


 
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