Anemia, HbA1c
Conditions
Keywords
Anemia, HbA1c
Brief summary
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?
Detailed description
Type of the study: \- Observational cross-sectional study. Site of the Study : \- Sohag University Hospital and hematology or endocrinology outpatient clinic. Study population: * 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. 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: * Complete blood count (CBC) with red cell indices (MCV, MCH, RDW). * Iron profile (for diagnosis of iron deficiency anemia) (Serum iron , Serum ferritin , Total iron-binding capacity (TIBC) , Transferrin saturation * HbA1c level and Fasting plasma glucose (FPG) to confirm non-diabetic status. * Vitamin Assessment ( Serum vitamin B12 level ) * Markers of Chronic Disease / Inflammation : C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)
Interventions
None listed
Sponsors
Sohag University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean HbA1c Level | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between HbA1c and Hemoglobin Concentration | At the time of enrollment | 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). |
| Correlation Between HbA1c and Mean Corpuscular Volume (MCV) | At the time of enrollment | 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). |
| Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH) | At the time of enrollment | 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). |
| Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC) | At the time of enrollment | 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). |
| Difference in HbA1c Across Anemia Severity Grades | At the time of enrollment | 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). |
| Correlation Between HbA1c and Serum Ferritin | At the time of enrollment | 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). |
| Correlation Between HbA1c and Serum Iron | At the time of enrollment | 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). |
| Correlation Between HbA1c and Total Iron-Binding Capacity (TIBC) | At the time of enrollment | 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). |
Countries
Egypt
Contacts
CONTACTMohamed Safwat
Outcome results
None listed