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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Usama A Arafa, Professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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