The Influence of Anemia on HbA1c Readings in Non-Diabetic Patients
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Anemia, HbA1c. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
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Официальное название
The Effect of Different Types of Anemia on HbA1c Levels in Non-Diabetics
Обзор
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?
Подробное описание
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)
Первичные конечные точки
- Mean HbA1c Level [Срок оценки: At the time of enrollment]
Вторичные конечные точки (8)
- Correlation Between HbA1c and Hemoglobin Concentration [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Volume (MCV) [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Hemoglobin (MCH) [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Mean Corpuscular Hemoglobin Concentration (MCHC) [Срок оценки: At the time of enrollment]
- Difference in HbA1c Across Anemia Severity Grades [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Serum Ferritin [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Serum Iron [Срок оценки: At the time of enrollment]
- Correlation Between HbA1c and Total Iron-Binding Capacity (TIBC) [Срок оценки: At the time of enrollment]
Критерии участия
Критерии включения
\- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Египет · 1 центр
- Sohag University Hospitals — Sohag
Идентификаторы
NCT: NCT07463612 · Soh-Med-26-2-12MS