Iron Deficiency AnemiaNCT04131608
Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)
An observational study of Iron Deficiency Anemia and HBA1C, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, HBA1C
- What is being tested?
- CBC ,Serum ferritin ,HBA1C
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients with diabetic foot ulcer grade one and two with or without iron deficiency anemia
Who may be able to join
- all diabetic patients with diabetic foot ulcer grade one and two above 18 year
Who cannot join
- patients with anemia other than iron deficiency anemia
- Patients on anticoagulants
- patients with blood disease 4-patients below 18
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the detailed 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
- Conditions
- Iron Deficiency Anemia, HBA1C
- Being tested
- CBC ,Serum ferritin ,HBA1C
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC ,Serum ferritin ,HBA1CDiagnostic test
Also called Ankle brachial index by duplex
Diabetic patients will be applied to CBC, HBA1C and serum ferritin
| Study group | Role | What they receive |
|---|---|---|
| diabetic foot ulcer (1and2)with iron defic | 50 diabetic patients with diabetic foot ulcer grade (1and2) with iron deficiency anemia will be applied TO
1. cbc
2. ferritin
3. HBA1C
4. ankle brachial index by duplex Receives: Diagnostic Test: CBC ,Serum ferritin ,HBA1C | |
| diabetic foot ulcer grade(1and2)without iron deficiency anemia | 50 patients with diabetic foot ulcer grade (1and2) without iron deficiency anemia will be applied to
1. CBC
2. Ferritin,
3. HBA1C
4. ankle brachial index by duplex Receives: Diagnostic Test: CBC ,Serum ferritin ,HBA1C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Feb 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MSSAMIR, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131608
- Sponsor's protocol ID
- HBA1C and anemia
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21679130American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available.
PubMed 20042775Kim 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.
PubMed 20067959Wolffenbuttel 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.
PubMed 23757434American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.
PubMed 24357215
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)
- ClinicalTrials.gov ID
- NCT04131608
- Acronym / sponsor ID
- HBA1C and anemia
- Conditions
- Iron Deficiency Anemia, HBA1C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
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
Detailed 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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic foot ulcer (1and2)with iron defic | – | Diagnostic Test: CBC ,Serum ferritin ,HBA1C50 diabetic patients with diabetic foot ulcer grade (1and2) with iron deficiency anemia will be applied TO 1. cbc 2. ferritin 3. HBA1C 4. ankle brachial index by duplex |
| diabetic foot ulcer grade(1and2)without iron deficiency anemia | – | Diagnostic Test: CBC ,Serum ferritin ,HBA1C50 patients with diabetic foot ulcer grade (1and2) without iron deficiency anemia will be applied to 1. CBC 2. Ferritin, 3. HBA1C 4. ankle brachial index by duplex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with diabetic foot ulcer grade one and two with or without iron deficiency anemia
Key inclusion criteria (1 listed)
- all diabetic patients with diabetic foot ulcer grade one and two above 18 year
Key exclusion criteria (3 listed)
- patients with anemia other than iron deficiency anemia
- Patients on anticoagulants
- patients with blood disease 4-patients below 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC ,Serum ferritin ,HBA1CAlso: Ankle brachial index by duplexDiabetic patients will be applied to CBC, HBA1C and serum ferritin | Diagnostic test | diabetic foot ulcer (1and2)with iron defic, diabetic foot ulcer grade(1and2)without iron deficiency anemia |
Primary outcome
Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients
Time frame: Base line
The influence of iron deficiency anemia on HBA1C in diabetic patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 21679130Kim 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.
- Background: PubMed 20042775American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available.
- Background: PubMed 20067959Kim 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.
- Background: PubMed 23757434Wolffenbuttel 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.
- Background: PubMed 24357215American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and HBA1C, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Samir Fawzy, Resident (01271389378, Drmarinasamirfawzy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131608, which also lists 5 linked publications.
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 13 Jan 2021.