跳至主要内容
临床试验/NCT07463612
NCT07463612尚未招募不适用

The Effect of Different Types of Anemia on HbA1c Levels in Non-Diabetics

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Mean HbA1c Level

研究概览

简要总结

The goal of this observational study is to learn about the effects of different types of anemia on HbA1c test results in non-diabetic adults who have anemia but do not have diabetes. The main question it aims to answer is:

- Do different types of anemia (iron deficiency, vitamin B12/folate deficiency, thalassemia, and anemia of chronic illness) cause HbA1c levels to be falsely high or low in people without diabetes?

详细描述

Type of the study:

- Observational cross-sectional study.

Site of the Study :

- Sohag University Hospital and hematology or endocrinology outpatient clinic.

Study population:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • - Adult participants aged 18 years and above.
  • Non-diabetic individuals, defined as:
  • Fasting plasma glucose < 126 mg/dL and/or
  • HbA1c < 6.5%, with no prior diagnosis of diabetes mellitus.
  • Individuals diagnosed with anemia based on WHO criteria:
  • Hemoglobin < 13 g/dL in males
  • Hemoglobin < 12 g/dL in female
  • Patients with hemolytic anemia including thalassemia ( thalassemia trait and intermediate ) , sickle cell ( trait and disease ).
  • Patients with confirmed specific types of anemia, based on laboratory evaluation:
  • Iron deficiency anemia
  • Vitamin B12 deficiency anemia
  • Folate deficiency anemia
  • Anemia of chronic diseases

排除标准

  • Known cases of diabetes mellitus or prediabetes.
  • Recent blood transfusion within the last 3 months.
  • Use of medications known to affect HbA1c levels
  • Acute illness or infection at the time of enrollment.
  • Pregnant women
  • Hematological malignancies

研究组 & 干预措施

Non anemic non-diabetics

Anemic non-diabetics

结局指标

主要结局

Mean HbA1c Level

时间窗: At the time of enrollment

Comparison of mean glycosylated hemoglobin (HbA1c) levels, measured as a percentage (%), between non-diabetic adults diagnosed with specific types of anemia (iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, and anemia of chronic disease) and a non-anemic control group.

次要结局

  • Correlation Between HbA1c and Hemoglobin Concentration(At the time of enrollment)
  • Correlation Between HbA1c and Mean Corpuscular Volume (MCV)(At the time of enrollment)
  • Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH)(At the time of enrollment)
  • Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC)(At the time of enrollment)
  • Difference in HbA1c Across Anemia Severity Grades(At the time of enrollment)
  • Correlation Between HbA1c and Serum Ferritin(At the time of enrollment)
  • Correlation Between HbA1c and Serum Iron(At the time of enrollment)
  • Correlation Between HbA1c and Total Iron-Binding Capacity (TIBC)(At the time of enrollment)

研究者

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

Mohamed Safwat Saad

Resident doctor in Internal Medicine Department

Sohag University

研究点 (1)

Loading locations...

相似试验