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Not yet recruitingNCT07463612Updated Mar 11, 2026

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

An observational study in Anemia and HbA1c, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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?

Read the 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)
02

Conditions studied

  • Anemia
  • HbA1c

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Keywords

  • Anemia
  • HbA1c
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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Anemic non-diabetics
  • Non anemic non-diabetics
06

What researchers measure

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

  5. 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).

    Time frame: At the time of enrollment

  6. 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).

    Time frame: At the time of enrollment

  7. 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).

    Time frame: At the time of enrollment

  8. 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).

    Time frame: At the time of enrollment

07

Study locations

1 site
  • Sohag University Hospitals
    Sohag, Sohag Governorate, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463612
Lead sponsor
Sohag University
Responsible party
Mohamed Safwat Saad (Resident doctor in Internal Medicine Department, Sohag University) — Principal investigator
First posted
Mar 11, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Mar 11, 2026

Study contacts

Mohamed Safwat
Contact
medologan@yahoo.com
+201009540535

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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