Relationship Between Red Cell Distribution Width (RDW) and HbA1C in Patients With Type 2 Diabetes Mellitus After Glycemic Control

April 1, 2024 updated by: Asmaa Nady Hussein, New Valley University
Diabetes mellitus (DM) is an epidemic disease, with approximately 463 million persons diagnosed with it. Of those, 90% are patients with type 2 DM (T2DM). Some estimates indicate that 700 million cases of DM will be reported in 2045. T2DM develops due to insulin resistance, leading to reduced insulin secretion. DM has a number of associated complications, such as nephropathy, neuropathy, and cardiovascular disease.

Study Overview

Detailed Description

The health status of normal individuals and patients with various diseases is commonly monitored using the complete blood count (CBC). In patients with T2DM, the CBC can be used as a follow-up test, which will help in reducing complications associated with the disease. Some CBC parameters have also been used as prognostic markers for T2DM. One of these markers is the red cell distribution width (RDW), which measures the variability in the sizes of red blood cells (RBCs) and is considered an indicator of their heterogeneity. The evidence associating RDW with a higher risk of mortality has been expanding since the initial report of its prognostic utility in heart failure patients. Multiple studies have shown that elevated RDW values are associated with many human diseases, such as cancer, cardiovascular disease, and diabetes, and are also associated with disease activity or complications of diseases. The RDW can be used diagnostically in patients with T2DM and other illnesses, as patients with T2DM frequently show alterations in various hematological properties, including changes in the structure, metabolism, and function of blood cells. These alterations can be caused by different factors, such as excessive levels of reactive oxygen species (ROS), leading eventually to oxidative stress and the dysfunction of RBCs.

The relationship between RDW and T2DM has been studied for several years, and there are no consistent results.

Study Type

Observational

Enrollment (Estimated)

250

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 Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed to have type 2 diabetes

Description

Inclusion Criteria:

  • Patients diagnosed to have Uncontrolled type 2 diabetes mellitus (HbA1C more than 7%)

Exclusion Criteria:

  1. Patients diagnosed to have type 1 diabetes.
  2. Patients are diagnosed to have secondary diabetes.
  3. Clinical states associated with increased RDW:

    • Anemia (Female Hb less than 12, Male Hb less than 13) either due to hemolysis, or in response to ineffective red cell production, which can be caused by deficiencies in iron, vitamin B12 or folate.
    • After blood transfusions
    • Pregnancy, thrombotic thrombocytopenic purpura and inflammatory bowel 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Diabetics
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
2
Healthy control
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control.
Time Frame: "At time of inclusion in the study", "3 months", "6 months"
"At time of inclusion in the study", "3 months", "6 months"

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if changes in RDW levels correlate with the presence of other comorbidities and complications.
Time Frame: once
once

Collaborators and Investigators

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

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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