Type 2 Diabetes Mellitus and Chronic Kidney Disease

January 6, 2024 updated by: Mohamed Khalaf Mohamed, Sohag University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We will classify study population into 3 groups First group those population with only type 2 diabetes mellitus Second group is those population with chronic kidney disease only Third group is those population with combined type 2 diabetes mellitus and chronic kidney disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

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
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
1 day
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
1 day
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 )
1 day
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
1 day
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
1 day
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
1 day
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-07-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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