The Influence of Anemia on HbA1c Readings in Non-Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anemia, HbA1c. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Different Types of Anemia on HbA1c Levels in Non-Diabetics
Overview
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)
Primary outcome measures
- Mean HbA1c Level [Time frame: At the time of enrollment]
Secondary outcome measures (8)
- Correlation Between HbA1c and Hemoglobin Concentration [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Volume (MCV) [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH) [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC) [Time frame: At the time of enrollment]
- Difference in HbA1c Across Anemia Severity Grades [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Serum Ferritin [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Serum Iron [Time frame: At the time of enrollment]
- Correlation Between HbA1c and Total Iron-Binding Capacity (TIBC) [Time frame: At the time of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Sohag University Hospitals — Sohag
Identifiers
NCT: NCT07463612 · Soh-Med-26-2-12MS