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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?
Type of the study:
- Observational cross-sectional study.
Site of the Study :
- Sohag University Hospital and hematology or endocrinology outpatient clinic.
Study population:
All patients included in the study will be subjected to:-
Medical history and clinical examination: Complete personal and family history with special emphasis on hematological disorders and history of diabetes or antidiabetic medications.
Laboratory investigations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anemic non-diabetics | |||
| Non anemic non-diabetics |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean HbA1c Level | 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. | At the time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between HbA1c and Hemoglobin Concentration | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels, measured as a percentage (%), and hemoglobin (Hb) concentration, measured in grams per deciliter (g/dL), across all study participants (including both anemic subgroups and non-anemic controls). | At the time of enrollment |
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Inclusion Criteria:
- 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:
Patients with confirmed specific types of anemia, based on laboratory evaluation:
Exclusion Criteria:
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Non-diabetic adult individuals attending the outpatient clinics and/or admitted to the internal medicine departments of Sohag University Hospital . Participants will be classified into different groups based on the presence and type of anemia (e.g., iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, anemia of chronic disease), in addition to a control group of non-anemic individuals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Safwat | Contact | +201009540535 | medologan@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospitals | Sohag | Sohag Governorate | Egypt |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Correlation Between HbA1c and Mean Corpuscular Volume (MCV) | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and mean corpuscular volume (MCV). HbA1c is measured as a percentage (%). MCV is measured in femtoliters (fL). | At the time of enrollment |
| Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH) | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and mean corpuscular hemoglobin (MCH). HbA1c is measured as a percentage (%). MCH is measured in picograms (pg). | At the time of enrollment |
| Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC) | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and mean corpuscular hemoglobin concentration (MCHC). HbA1c is measured as a percentage (%). MCHC is measured in grams per deciliter (g/dL). | At the time of enrollment |
| Difference in HbA1c Across Anemia Severity Grades | Comparison of mean glycosylated hemoglobin (HbA1c) levels, measured as a percentage (%), among participants categorized by anemia severity grades (mild, moderate, and severe) based on hemoglobin concentration thresholds established by the World Health Organization (WHO). | At the time of enrollment |
| Correlation Between HbA1c and Serum Ferritin | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and serum ferritin levels. HbA1c is measured as a percentage (%). Serum ferritin is measured in micrograms per liter (µg/L). | At the time of enrollment |
| Correlation Between HbA1c and Serum Iron | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and serum iron levels. HbA1c is measured as a percentage (%). Serum iron is measured in micrograms per deciliter (µg/dL). | At the time of enrollment |
| Correlation Between HbA1c and Total Iron-Binding Capacity (TIBC) | Evaluation of the correlation between glycosylated hemoglobin (HbA1c) levels and total iron-binding capacity (TIBC). HbA1c is measured as a percentage (%). TIBC is measured in micrograms per deciliter (µg/dL). | At the time of enrollment |