Type 2 Diabetes Mellitus and Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of co existance of diabetes mellitus and chronic kidney disease on basic coagulation profile in comparison with diabetic patients with normal kidney function and non diabetic patients with chronic kidney disease

Detailed Description
-----------------
We will study impact of type 2 diabetes mellitus on basic coagulation profile and platelet indices among patients with chronic kidney disease

Official Title
-----------------
Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Patients With Chronic Kidney Disease

Conditions
-----------------
Renal Disorder Associated With Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus with and without chronic kidney disease Patients with chronic kidney disease without diabetes mellitus Exclusion Criteria: any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Co existance of diabetes mellitus and chronic kidney disease<br>Study basic coagulation profile and platelet indices among those patients with combined diabetes mellitus and chronic kidney disease | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease<br>* Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease<br>|
| Diabetes mellitus without chronic kidney disease<br>Study basic coagulation profile and platelet indices among those patients with diabetes mellitus only | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease<br>* Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease<br>|
| Chronic kidney disease without diabetes mellitus<br>Study basic coagulation profile and platelet indices among those patients with chronic kidney disease without diabetes mellitus | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease<br>* Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time | We will include 150 patients and classify them into 3 groups each one consists of 50 patients First group those patients with diabetes mellitus only Second group those patients with chronic kidney disease only Third group those patients with combined diabetes mellitus type 2 and chronic kidney disease not on hemodialysis First we will measure prothrombin time | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration | We will include 150 patients classified into 3 groups as previous Second measure is prothrombin concentration | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by INR | We will include 150 patients as previous Third measure is INR ( international normalised ratio ) | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time | We will include 150 patients as previous Fourth measure is partial thromboplastin time | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen | We will include 150 patients as previous Fifth measure is serum fibrinogen level in the 3 groups | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume | We will include 150 patients as previous Sixth measure is mean platelet volume in the 3 groups | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width | We will include 150 patients as previous Seventh measure is platelet distribution width for the 3 groups | 1 day | 
| Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit | We will include 150 patients as previous Eighth measure is plateletcrit of the 3 study groups | 1 day |