Skip to main content
OpenTrials
Completed

NCT Number: NCT04971252

Type 2 Diabetes Mellitus and Chronic Kidney Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematologic tests for patients with diabetes mellitus and chronic kidney disease

Diagnostic Test

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

Primary outcomes

  1. Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time

    Time frame: 1 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

  2. Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration

    Time frame: 1 day

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

  3. Estimate risk of thrombosis or bleeding for the 3 study groups by INR

    Time frame: 1 day

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

  4. Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time

    Time frame: 1 day

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

  5. Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen

    Time frame: 1 day

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

  6. Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume

    Time frame: 1 day

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

  7. Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width

    Time frame: 1 day

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

  8. Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.