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

Sponsor
New Valley University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06067399
Collaborator
(none)
250
18.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Glycated hemoglobin (HbA1C)
  • Diagnostic Test: RDW
  • Diagnostic Test: Lipid profile

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Relationship Between Red Cell Distribution Width (RDW) and HbA1C in Patients With Type 2 Diabetes Mellitus After Glycemic Control
Anticipated Study Start Date :
Dec 25, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
1

Prediabetics

Diagnostic Test: Glycated hemoglobin (HbA1C)
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: RDW
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: Lipid profile
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

2

Diabetics

Diagnostic Test: Glycated hemoglobin (HbA1C)
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: RDW
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: Lipid profile
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

3

Healthy control

Diagnostic Test: Glycated hemoglobin (HbA1C)
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: RDW
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Diagnostic Test: Lipid profile
Blood test will be done at time of recruitment (for 3 groups) , after 3 months and after 6 months (for group 1 and 2)

Outcome Measures

Primary Outcome Measures

  1. To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control. ["At time of inclusion in the study", "3 months", "6 months"]

Secondary Outcome Measures

  1. To determine if changes in RDW levels correlate with the presence of other comorbidities and complications. [once]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients diagnosed to have type 2 diabetes or prediabetics
Exclusion Criteria:
  • Patients diagnosed with type 1 diabetes.

  • Patients are diagnosed with secondary diabetes.

  • Patients with anemia

  • Patients with liver disease, or any other significant comorbidities that may affect RDW or HbA1C levels

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • New Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asmaa Nady Hussein, Lecturer of Internal Medicine and Clinical Hematology, New Valley University
ClinicalTrials.gov Identifier:
NCT06067399
Other Study ID Numbers:
  • T2DMRDW
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Oct 4, 2023