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NCT Number: NCT06067399

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New Valley University- Faculty of Medicine

Al Khārjah, Egypt

Location status: Recruiting

Location contact

Asmaa Hussein, MD

CONTACT

[email protected]

01065161752

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients diagnosed to have type 1 diabetes.
  • Patients are diagnosed to have secondary diabetes.
  • 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.

Treatment and study plan

Glycated hemoglobin (HbA1C)

Diagnostic Test

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

RDW

Diagnostic Test

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

Lipid profile

Diagnostic Test

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

Primary outcomes

  1. 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"

Secondary outcomes

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

    Time frame: once

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa N Hussein, MD

CONTACT

[email protected]

01065161752

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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