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

March 8, 2026 updated by: Mohamed Safwat Saad, Sohag University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

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)

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt
        • Sohag university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Anemic non-diabetics
Non anemic non-diabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean HbA1c Level
Time Frame: 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.
At the time of enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-2-12MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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