AnemiaNCT07463612
The Influence of Anemia on HbA1c Readings in Non-Diabetic Patients
An observational study of Anemia and HbA1c, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospitals
Sohag, Sohag Governorate
Mohamed Safwat, +201009540535, medologan@yahoo.com
About this study
Official title: 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?
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)
- Keywords
- Anemia, HbA1c
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anemic non-diabetics | Not described | |
| Non anemic non-diabetics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of enrollment
Secondary outcomes (8)
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
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).
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Safwat Saad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463612
- Sponsor's protocol ID
- Soh-Med-26-2-12MS
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Anemia on HbA1c Levels in Non-Diabetics
- ClinicalTrials.gov ID
- NCT07463612
- Acronym / sponsor ID
- Soh-Med-26-2-12MS
- Keywords
- Anemia, HbA1c
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemic non-diabetics | – | – |
| Non anemic non-diabetics | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and HbA1c, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Safwat (+201009540535, medologan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean HbA1c Level (time frame: At the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.