| 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
|
|
|
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
|
|
|
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.
|