The Influence of Anemia on HbA1c Readings in Non-Diabetic Patients

ConditionsAnemiaHbA1c
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSohag University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Fasting plasma glucose < 126 mg/dL and/or

HbA1c < 6.5%, with no prior diagnosis of diabetes mellitus.

Hemoglobin < 13 g/dL in males

Hemoglobin < 12 g/dL in female

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Anemic non-diabetics
Group B: Non anemic non-diabetics

Trial outcomes

Primary outcomes

1

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.

Time frame
At the time of enrollment

Secondary outcomes

1

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).

Time frame
At the time of enrollment
2

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).

Time frame
At the time of enrollment
3

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).

Time frame
At the time of enrollment
4

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).

Time frame
At the time of enrollment

Other outcomes

Sponsors and contacts

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