| CTRI Number |
CTRI/2023/03/050301 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Iron Deficiency Anemia on indicator of long term control of Diabetes Mellitus in Persons without Diabetes Mellitus |
|
Scientific Title of Study
|
Effect of Iron Deficiency Anemia on Glycated Hemoglobin in Persons without Diabetes Mellitus |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Bhat |
| Address |
Dr TMA Pai Hospital, MAHE, Brahmagiri
Udupi
KARNATAKA
576101
India |
| Phone |
9538447768 |
| Fax |
|
| Email |
aishwarya.sairam@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shashikiran Umakanth |
| Address |
Dr TMA Pai Hospital, MAHE, Brahmagiri
Udupi
KARNATAKA
576101
India |
| Phone |
9008418171 |
| Fax |
|
| Email |
shashikiran.u@manipal.edu |
|
Details Contact Person
Public Query
|
| Name |
Dr Aishwarya Bhat |
| Address |
Dr TMA Pai Hospital, MAHE, Brahmagiri
Udupi
KARNATAKA
576101
India |
| Phone |
9538447768 |
| Fax |
|
| Email |
aishwarya.sairam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr TMA Pai Hospital, MAHE, Udupi |
|
|
Primary Sponsor
|
| Name |
Dr TMA Pai Hospital |
| Address |
Dr TMA Pai Hospital, MAHE, Brahmagiri, Udupi, Karnataka 576101 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishwarya Bhat |
Dr TMA Pai Hospital |
Room number 4, 1st floor, OPD Block, Department of General Medicine, Dr TMA Pai Hospital, MAHE, Brahmagiri, Udupi, Karnataka - 576101
Udupi
|
9538447768
aishwarya.sairam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Iron deficiency anemia, unspecified |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Age > 18years 2) Presence of anemia as defined by WHO: Hemoglobin < 13.0 g/dl (adult males) & < 12.0 g/dl (non-pregnant women) 3) Microcytic, hypochromic or microcytic, normochromic picture in peripheral blood smear 4) Fasting blood glucose levels < 126mg/dl and post prandial blood glucose levels < 200mg/dl |
|
| ExclusionCriteria |
| Details |
1) Previously known cases of Type 1 Diabetes Mellitus and Type 2
Diabetes Mellitus
2) Hemolytic anemias
3) Known hemoglobinopathies and Red blood cell disorders
4) Acute infections
5) Acute organ failures
6) Chronic alcohol ingestion
7) Chronic renal failure
8) Patients on iron therapy
9) Pregnant women
10) Documented past history of gestational diabetes (GDM)
11) History of blood loss or blood transfusion in the past 3 months.
12) Documented history of endocrine disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Glycated Hemoglobin values in Persons without Diabetes Mellitus with and without Iron Deficiency Anemia |
Primary outcome will be assessed on the day of hospital visit, no follow up is involved in this trial. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Fasting Blood Sugar and Postprandial Blood Sugar levels in Persons without Diabetes Mellitus with and without Iron Deficiency Anemia |
Secondary outcome will be assessed on the day of hospital visit, no followup involved in the trial. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
06/03/2023 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
None yet |
|
Brief Summary
|
Glycated hemoglobin (HbA1c), which is a valuable tool in monitoring the glycemic control, is also recommended for diagnosing Diabetes Mellitus (DM). It is important to exclude factors which could spuriously elevate the level of HbA1c and lead to misdiagnosis of DM. Iron deficiency anemia (IDA) is the commonest nutritional anemia worldwide. Reports on the effects of IDA on HbA1c levels were inconsistent. This study is being proposed to assess whether IDA has any effect on HbA1c levels, and whether it should be considered before making any diagnostic or therapeutic decisions solely based on HbA1c levels. |
