Type 2 Diabetes Mellitus and Chronic Kidney Disease

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04971252
Collaborator
(none)
150
24

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hematologic tests for patients with diabetes mellitus and 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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Patients With Chronic Kidney Disease
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Co existance of diabetes mellitus and chronic kidney disease

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

Diabetes mellitus without chronic kidney disease

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

Chronic kidney disease without diabetes mellitus

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Khalaf Mohamed, Assistant lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT04971252
Other Study ID Numbers:
  • Soh-Med-21-07-24
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021