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

NCT07463612 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-2-12MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Anemia; HbA1c

Keywords

Anemia; HbA1c

Outcome Measures

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.

  At the time of enrollment

Secondary Outcomes (8)

• Correlation Between HbA1c and Hemoglobin Concentration

  At the time of enrollment

• Correlation Between HbA1c and Mean Corpuscular Volume (MCV)

  At the time of enrollment

• Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH)

  At the time of enrollment

• Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC)

  At the time of enrollment

• Difference in HbA1c Across Anemia Severity Grades

  At the time of enrollment

Study Arms (2)

Anemic non-diabetics

Non anemic non-diabetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Mohamed Safwat

CONTACT

+201009540535; medologan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor in Internal Medicine Department

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-02

Locations

EG (1)