serum ferritin and diabetes

1. ASSOCIATION BETWEEN SERUM
FERRITIN AND DURATION OF
TYPE 2 DM IN A TERTIARY CARE
HOSPITAL IN CHENNAI
INVESTIGATOR:
DR. A.SANKAR
Associate Professor
Department of General Medicine, SBMCH
CO INVESTIGATOR:
Dr.S.ANBALAGAN
JR - Department of General Medicine SBMCH

2. INTRODUCTION
• Hyperinsulinemia inT2DM is known to increase
ferritin synthesis and iron uptake.
• Increase iron store is associated with glucose
intolerance.
• Iron increases oxidative stress which inhibits
internalisation and action of insulin.
• This study hypothesises that increased body iron
store is responsible for
1. The development of insulin resistance and
2. Glucose intolerance as well as
3. Vascular complications of diabetes.

3. RATIONALE OF THE STUDY
• The significance of iron in pathophysiology of diabetes is
derived from the ease with which iron is reversibly oxidized
and reduced as it plays a critical role in Haber Weis reaction
producing ractive oxygen species.
• Iron is supposed to involve in influencing diabetes by three
mechanism ;
– (a)Insulin deficiency- as pancreatic islet are extremely sensitive
to free radical oxidative damage, iron deposited into pancreatic
interstitial cells result into collagen deposition and defective
microcirculation,
– (b)insulin resistance and
– (c) hepatic dysfunction.
• Increased body iron increases the incidence of diabetic
complication due to free radical injury and is positively and
independently associated with the prevalence of the
metabolic syndrome, increased fasting glucose and
dyslipidemia.

4. BACKGROUND AND STATEMENT OF
THE PROBLEM
• Diabetes frequently develops in the individual with iron
overload disease such as Hemochromatosis and recurrent
transfusions in disease like thalassemia.
• Hydroxyl radical may attack pancreatic beta cells through
oxidative stress and thus results in impaired insulin synthesis
and excretion.
• Pancreatic islet cells are more susceptible than other tissue due
to lower level of antioxidant enzyme such as Superoxide
dismutase, Catalase and Glutathione peroxidase. Plebotomy
improves insulin sensitivity. Serum ferritin is biomarker for iron
store and ferritin increases in response to inflammatory stress.
• Purpose of this study is to see whether a relationship exists
between increased serum ferritin and duration of diabetes and
to consolidate the hypothesis.

5. AIM
• ASSOCIATION BETWEEN SERUM FERRITIN AND
DURATION OF TYPE 2 DM IN A TERTIARY CARE
HOSPITAL IN CHENNAI

6. OBJECTIVE
• To estimate serum ferritin and fasting plasma glucose
in diabetes and non-diabetes and to find out the
correlation between them.
• To find out the correlation between serum ferritin
and the duration of diabetes mellitus in diabetic
group.

7. METHODOLOGY
• DESIGN : CROSS-SECTIONAL STUDY
• PLACE : SREE BALAJI MEDICAL COLLEGE AND HOSPITAL
• TIME : 3 MONTHS
• SAMPLE VOLUME: 75
• SAMPLING METHOD:
– 38 CLINICALLY DIAGNOSED TYPE 2 DIABETES MELLITUS MALE AND
37 HEALTHY MALE VOLUNTEER WERE INCLUDED .
– FASTING BLOOD SAMPLE WERE TAKEN AND PLASMA GLUCOSE
AND SERUM FERRITIN WILL BE ESTIMATED.

8. SAMPLE SIZE CALCULATION:
Sample Size = 75
Minimum Sample Size (N) = Z21-a/2)PQ / d²
N = (1.96)2x(73)x(27) / 49
N = 75 (Minimum sample size)
Z21-a/2) = (1.96)2 (95% level of confidence)
P = Approximate proportion of people who may have outcome
Q = 1-P
d = Margin of error (10%)

9. INCLUSION CRITERIA
• UNCOMPLICATED TYPE 2 DIABETIC MALES OF
AGE BETWEEN 25-70 YEARS WITH A BODY
MASS INDEX BETWEEN 19-40 KG PER METER
SQUARE.
• CONTROL GROUP CONSIST OF AGE MATCHED
HEALTHY MALE VOLUNTEERS HAVING FASTING
BLOOD GLUCOSE LEVEL LESS THAN 100
MG/DL.

10. EXCLUSION CRITERIA
• AGE LESS THN 25 AND MORE THAN 70
• FEMALE were not included in this study because
menstruation affects serum ferritin level due to blood loss,
serum ferritin measured during menstrual phase shows
lower values than that measured during luteal and late
luteal phase.
• Patients having confounding comorbidity like TYPE 1
DIABETES
• HEMOCHROMATOSIS
• CHRONIC ALCOHOLICS
• CHRONIC INFLAMMATORY CONDITIONS LIKE
– SLE
– HEPATITIS
• PATIENTS WITH REPEATED BLOOD TRANSFUSION
• IRON DEFICIENCY ANAEMIA

11. EXCLUSION CRITERIA
• RECENT HISTORY OF BLOOD LOSS
– BLEEDING PILES
– RECENT HISTORY OF MAJOR SURGERY
• DIABETIC FOOTS
• HYPOTHYROIDISM
• CARDIOVASCULAR DISORDER
• DIABETIC NEPHROPATHY
• ANAEMIA OF ANY CAUSES
• HISTORY OF MALIGNANCY OR CHEMOTHERAPY
• PATIENTS TAKING ANTI INFLAMMATORY DRUGS

12. INCLUSION CRITERIA
•UNCOMPLICATED TYPE 2
DIABETIC MALES OF AGE
BETWEEN 25-70 YEARS
WITH A BODY MASS INDEX
BETWEEN 19-40 KG PER
METER SQUARE.
•CONTROL GROUP CONSIST
OF AGE MATCHED HEALTHY
MALE VOLUNTEERS
HAVING FASTING BLOOD
GLUCOSE LEVEL LESS THAN
100 MG/DL.
EXCLUSION CRITERIA
•AGE LESS THN 25 AND MORE
THAN 70
•FEMALE were not included in this study
because menstruation affects serum
ferritin level due to blood loss, serum
ferritin measured during menstrual
phase shows lower values than that
measured during luteal and late luteal
phase.
•Patients having confounding
comorbidity like TYPE 1 DIABETES
•HEMOCHROMATOSIS
•CHRONIC ALCOHOLICS
•CHRONIC INFLAMMATORY CONDITIONS
LIKE
•SLE
•HEPATITIS
•PATIENTS WITH REPEATED
BLOOD TRANSFUSION
•IRON DEFICIENCY ANAEMIA
•RECENT HISTORY OF BLOOD LOSS
•BLEEDING PILES
•RECENT HISTORY OF MAJOR SURGERY
•DIABETIC FOOTS
•HYPOTHYROIDISM
•CARDIOVASCULAR DISORDER
•DIABETIC NEPHROPATHY
•ANAEMIA OF ANY CAUSES
•HISTORY OF MALIGNANCY OR
CHEMOTHERAPY
•PATIENTS TAKING ANTI INFLAMMATORY
DRUGS
PARTICIPANTS WHO
FIT FOR INCLUSION
CRITERIA
ALL PARTICIPANTS
SUBJECTED TO
DETAILED CLINICAL,
GENERAL AND
SYSTEMIC
EXAMINATION
WITH ADVISED LAB
INVESTIGATIONS
CORRELATION OF
SERUM FERRITIN
AND DURATION OF
TYPE 2 DM WITH
HEALTHY
INDUVIDUAL
METHODOLOGY

13. DATA COLLECTION METHODS
• General and Systemic examination Blood
Investigations such as
• Serum ferritin
• Serum plasma glucose
• DATA COLLECTION TOOLS
• Specially designed proforma

14. DATA ANALYSIS METHODS
• Qualitative variables will be assessed in
frequency and percentage
• Chi squared test will be used to assess the
association between the variables
• Difference in parametric distribution between
the variables will be assessed using T-test

15. EXPECTED BENEFITS OF THE STUDY
• Purpose of this study is to see whether a
relationship exist between increased serum
ferritin and duration of diabetes and to
consolidate the hypothesis.
• So that we can prevent incidence of diabetes
and complications in impaired plasma glucose
candidates.

16. PARTICIPANTS IN THE STUDY:
• The Investigator (Self)
• Participants who take part in the study

17. ETHICAL CONSIDERATIONS
•
• DOES THE STUDY INCLUDE HUMAN SUBJECTS OR ANIMALS?
– Human subjects: - YES.
– Animals: - NO
• ARE PATIENTS INVOLVED IN THIS STUDY?
– Yes
• ARE STUDENTS SUBJECTS OF THIS STUDY?
– No
• WHAT IS THE SAMPLE SIZE REQUIRED FOR THIS STUDY?
– 75 Patients
• IS THE PROCEDURE INVASIVE? GIVE DETAILS ABOUT THE BIOLOGICAL SAMPLES.
– Yes, the procedure is invasive. Blood samples for laboratory analysis will be collected.
• RISKS OF THE PROCEDURE INVOLVED?
– Nil
• WILL THE SUBJECTS BE INVOLVED IN ANY OTHER EXPERIMENTATION DURING THE STUDY?
– No
• PERSONAL EXPERIENCE OF THE INVESTIGATOR WITH THE PROPOSED TECHNIQUE
– Yes
• DETAILS OF INFORMED CONSENT APPENDED (IN LOCAL LANGUAGE) ?
– Standard written informed consent of the patient or patient's relative for participating in the study
and for collection of Biological Samples will be taken.
• REMUNERATIONS TO THE SUBJECTS
– Nil

18. COMMENCEMENT OF THE PROJECT
AND DATE OF COMPLETION OF THE
PROJECT
• Date of Commencement : 01/04/2023
• Date of Completion : 30/06/2023

19. PROFORMA
DETAILS
– NAME:
– AGE:
– SEX:
– IP/OP NO:
– DOA:
– DOD:
PRESENT COMPLAINTS:
PAST HISTORY (WITH DURATION):
– DM:
– HTN:
– IHD:
– CKD:
– BRONCHIAL ASTHMA:
– HYPOTHYROIDISM:
– OLD CVA:
– OLD TB:
– OTHERS:
HABITS (WITH DURATION):
– ALCOHOL:
– SMOKING:
– OTHERS:
VITALS:
• TEMPERATURE:
• PULSE:
• BP:
• RR:
• SpO2:
GENERAL EXAMINATION:
• CONSCIOUSNESS:
• ORIENTATION:
• PALLOR:
• ICTERUS:
• CYANOSIS:
• CLUBBING:
• LYMPHADENOPATHY:
• EDEMA:
• SKIN LESIONS:
SYSTEMIC EXAMINATION:
• CVS:
• RS:
• CNS:
• PA:
DIAGNOSIS:
:
• INVESTIGATIONS:
• SERUM FERRITIN:
•
• SERUM PLASMA GLUCOSE:

20. REFERENCE
1. Sundararaman Swaminathan, Vivian A. Fonseca,
Muhammad G. Alam, Sudhir Shah, The role of iron in
diabetes and its complications, Diabetes Care; july
2007; 30(7); 1926-1933.
2. Megan Jehn, Jeanne M Clark, Eliseo Guallar, Serum
Ferritin and Risk of the Metabolic Syndrome in U.S.
Adults, Diabetes Care; Oct 2004; 27(10); 2422-2428.
3. C E Wrede, R Buettner, L C Bollheimer, J Scho¨lmerich,
K-D Palitzsch1 and C Hellerbrand, Association between
serum ferritin and the insulin resistance syndrome in a
representative population, European Journal of
Endocrinology; 154; 2006; 333–340.

21. THANK YOU