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Type 2 Diabetes Mellitus and Chronic Kidney Disease

Completed
Conditions
Renal Disorder Associated With Type II Diabetes Mellitus
Interventions
Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease
Registration Number
NCT04971252
Lead Sponsor
Sohag University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Co existance of diabetes mellitus and chronic kidney diseaseHematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with combined diabetes mellitus and chronic kidney disease
Diabetes mellitus without chronic kidney diseaseHematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with diabetes mellitus only
Chronic kidney disease without diabetes mellitusHematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with chronic kidney disease without diabetes mellitus
Primary Outcome Measures
NameTimeMethod
Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time1 day

We will include 150 patients as previous Fourth measure is partial thromboplastin time

Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen1 day

We will include 150 patients as previous Fifth measure is serum fibrinogen level in the 3 groups

Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width1 day

We will include 150 patients as previous Seventh measure is platelet distribution width for the 3 groups

Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time1 day

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

Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit1 day

We will include 150 patients as previous Eighth measure is plateletcrit of the 3 study groups

Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration1 day

We will include 150 patients classified into 3 groups as previous Second measure is prothrombin concentration

Estimate risk of thrombosis or bleeding for the 3 study groups by INR1 day

We will include 150 patients as previous Third measure is INR ( international normalised ratio )

Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume1 day

We will include 150 patients as previous Sixth measure is mean platelet volume in the 3 groups

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sohag University

🇪🇬

Sohag, Egypt

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