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Type 2 Diabetes Mellitus and Chronic Kidney Disease

Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Non-dialysis Chronic Kidney Disease Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04971252
Enrollment
150
Registered
2021-07-21
Start date
2021-07-07
Completion date
2023-07-07
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

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

Interventions

DIAGNOSTIC_TESTHematologic tests for patients with diabetes mellitus and chronic kidney disease

Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time1 dayWe 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 prothrombin concentration1 dayWe 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 dayWe 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 partial thromboplastin time1 dayWe 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 dayWe 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 mean platelet volume1 dayWe will include 150 patients as previous Sixth measure is mean platelet volume in the 3 groups
Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width1 dayWe 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 plateletcrit1 dayWe will include 150 patients as previous Eighth measure is plateletcrit of the 3 study groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026