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NCT04131608 Clinical Trial

Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Iron Deficiency Anemia Clinical Trial

Official title:
Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04131608
Other study ID # HBA1C and anemia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 1, 2021

Study information
Verified date October 2020
Source Assiut University
Contact Marina Samir Fawzy, Resident
Phone 01271389378
Email Drmarinasamirfawzy@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

Description:

HBA1C is the predominant Hemoglobin found in HBA1 fraction and it constitutes 5% of total Hemoglobin in normal adults and up to 15%in patients with diabetes mellitus HBA1C is used to diagnose diabetes and to identify individuals that are at high risk for developing diabetes Iron deficiency anemia is one of the most prevalent form of malnutrition affect 1,62 billion people whish correspond to 24,8%of the world population Ferritin is the storage form of iron so it is found to be test for distinguishing those with iron deficiency anemia from those who are not iron deficient

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all diabetic patients with diabetic foot ulcer grade one and two above 18 year Exclusion Criteria: 1. patients with anemia other than iron deficiency anemia 2. Patients on anticoagulants 3. patients with blood disease 4-patients below 18

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CBC ,Serum ferritin ,HBA1C
Diabetic patients will be applied to CBC, HBA1C and serum ferritin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (5)

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1:S62-9. doi: 10.2337/dc10-S062. Erratum in: Diabetes Care. 2010 Apr;33(4):e57. — View Citation

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. — View Citation

Kim C, Bullard KM, Herman WH, Beckles GL. Association between iron deficiency and A1C Levels among adults without diabetes in the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care. 2010 Apr;33(4):780-5. doi: 10.2337/dc09-0836. Epub 2010 Jan 12. — View Citation

Kim S, Min WK, Chun S, Lee W, Park HI. Glycated albumin may be a possible alternative to hemoglobin A1c in diabetic patients with anemia. Clin Chem Lab Med. 2011 Oct;49(10):1743-7. doi: 10.1515/CCLM.2011.646. Epub 2011 Jun 17. — View Citation

Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients The influence of iron deficiency anemia on HBA1C in diabetic patients Base line
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