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临床试验/NCT06067399
NCT06067399招募中不适用

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

New Valley University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control.

时间窗: "At time of inclusion in the study", "3 months", "6 months"

次要结局

  • To determine if changes in RDW levels correlate with the presence of other comorbidities and complications.(once)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Nady Hussein

Lecturer of Internal Medicine and Clinical Hematology

New Valley University

研究点 (2)

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