RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDIDATE AND ADDRESS / DR.UJWALA N JAGDALE#608, ‘RAJVILAS’ , 15TH CROSS , JP NAGAR 1ST PHASE,
BANGALORE – 560078. KARNATAKA. INDIA.
2. NAME OF THE INSTITUTION / RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL ,
KAMBIPURA , MYSORE ROAD,
BANGALORE – 560074.
KARNATAKA. INDIA.
3. COURSE OF STUDY AND SUBJECT / MD [ PHYSIOLOGY ]
4. DATE OF ADDMISSION / 31st OF MAY 2012
5. TITLE OF THE TOPIC / “A COMPARATIVE STUDY OF ANAEMIA WITH THE DEGREE OF GLYCAEMIC CONTROL IN TYPE 2 DIABETES MELLITUS ”
6. BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR THE STUDY: There are currently approximately 40.9 million patients with diabetes mellitus in India and this number is expected to rise to about 69.9 million by the year 2025. This high burden of diabetes is likely to be associated with an increase in associated complications.1
Type 2 Diabetes Mellitus is a non-autoimmune, complex, heterogeneous and polygenic metabolic disease condition in which the body fails to produce enough insulin, characterized by abnormal glucose homeostasis. Its pathogenesis appears to involve complex interactions between genetic and environmental factors. Type 2 Diabetes Mellitus occurs when impaired insulin effectiveness (insulin resistance) is accompanied by the failure to produce sufficient cell insulin.
In type 2 diabetes mellitus patients glycosylated haemoglobin (HbA1c) is an effective tool in monitoring long term blood glucose control.HbA1c gives an accurate estimate of the average of the plasma glucose levels from the past 8 to 12 weeks. Hence glycosylated haemoglobin becomes an important marker of glycemic control in diabetes mellitus.
HbA1c testing is a measure of diabetic glycaemic control. Diabetes control is categorized as poor control (HbA1c levels > 9%), moderate control (HbA1c levels between 7% and 9%) and good or desired control (HbA1c levels <7%).2
Anaemia is one of the world’s most common preventable condition yet it is often overlooked especially in people with Diabetes Mellitus.3
Anaemia is a common finding in patients with diabetes. Diabetes related chronic hyperglycaemia can lead to a hypoxic environment in the renal interstitium which results in impaired production of erythropoietin by the peritubular fibroblasts and subsequently anaemia occurs.3
Anaemia in patients with diabetes mellitus might contribute to pathogenesis and progression of cardiovascular disease and aggravate diabetic nephropathy and retinopathy. However, an emphasis on regular screening for anaemia, alongside that for other diabetes – related complications, might help to delay the progression of vascular complication in these patients.3
6.2 REVIEW OF LITERATURE :
Anaemia may be more common in diabetes and develop earlier than in patients with renal impairment from other causes. However, patients with diabetes may be more vulnerable to the effects of anaemia because many also have significant cardiovascular disease and hypoxia – induced organ damage.4
Although anaemia can be considered a marker of kidney damage, reduced hemoglobin levels independently identify diabetic patients with an increased risk of microvascular complications, cardiovascular disease and mortality.5
Many factors have been suggested as the reason for the earlier onset of anaemia in patients with diabetes, including severe symptomatic autonomic neuropathy, causing efferent sympathetic denervation of the kidney and loss of appropriate erythropoietin production; damage to the renal interstitium; systemic inflammation; and inhibition of erythropoietin release.6
In spite of the plethora of reports on the presence of anaemia in diabetic patients with renal insufficiency, limited study exists on the incidence of anaemia in diabetics prior to the evidence of renal impairment. This may explain why most diabetic patients with normal renal function are rarely tested for anaemia. The need for more studies on incidence of anaemia in diabetic patients prior to renal impairment has therefore become imperative, in order to increase the level of awareness and understanding of anaemia amongst diabetic patients.7
Correction of the anaemia not only lessens fatigue, greater exercise tolerance, and an improved quality of life but also to a reduction in outpatient and hospital admissions for congestive heart failure. Data are accumulating that suggestive treatment of anaemia will slow the progression of microvascular and macrovasular complications including postural hypotension from autonomic neuropathy, retinopathy and diabetic nephropathy. Promptly diagnosing and treating anaemia in patients with diabetes may result in improved quality of life and decreased morbidity and mortality.8
6.3 OBJECTIVES OF THE STUDY:
1. To compare the hemoglobin levels among normal controls and patients of type 2 diabetes with HbA1c levels :
i) Below 7 %
ii) Above 7 %
2. To identify the undetected cases of anaemia in type 2 diabetes.
7. MATERIALS AND METHODS:
7.1a SOURCE OF DATA
35 patients of type 2 diabetes mellitus with their glycosylated hemoglobin levels less than 7 %,
35 patients of type 2 diabetes mellitus with their glycosylated hemoglobin levels more than 7 % attending the Medicine outpatient department of Rajarajeswari Medical College and Hospital will be the subjects for the study.
35 age and sex matched controls will be selected randomly from in and around Rajarajeswari Medical College and Hospital.
Informed written consent will be taken from all the subjects. The study will be conducted from January 2013 to January 2014.
7.2a INCLUSION CRITERIA:
· Males and Females aged 35 to 65 years.
· Clinically proven cases of type 2 diabetes mellitus with Anaemia attending the medicine outpatient department of Rajarajeswari Medical College and Hospital.
7.2b EXLUSION CRITERIA:
· Other causes of Anaemia not associated with Diabetes
· Associated co- morbid conditions like Hypertension, Congestive Cardiac Failure, Chronic Renal Failure, Stroke, Haemorrhological Disorders and Malignancy.
· Obstetric and Gynecological Disorders
· Patients on Hormone Therapy
· Pregnancy
· Patient not willing to give consent for the study.
7.2 METHOD OF COLLECTION OF DATA
All the subjects and control will be generally and systemically examined to rule out the presence of other co – morbid conditions.
Anthropometry: Height, Weight, BMI will be measured, waist to hip ratio will be collected.
A questionnaire will be provided to the controls and subjects to know about their lifestyle, past history, family history and list of medications.
(ANNEXURE 1 attached)
Blood sample from the study and control group will be drawn under complete aseptic precautions, (ANNEXURE 2 attached) after obtaining informed consent. (ANNEXURE 3 attached)
Fasting and two hours post prandial blood sample will be collected for analysis in vacuum evacuated tubes as follows:
1. Clot activator containing vacuum evacuated tubes for estimation of Complete Haemogram, Peripheral Blood Smear, Renal Function Test and Iron Profile.
2. Fluorides EDTA vacuum evacuated tubes for estimation of blood glucose and glycosylated hemoglobin.
3. Sterile Urine container for the analysis of Urine Glucose and Urine Microscopy.
4. Sterile stool container for the analysis of Stool Microscopy.
7.2 PLAN FOR DATA ANALYSIS
The results will be analysed using the SPSS software 16th version.
ANOVA and paired “ t” tests will be used for statistical analysis of the data. All the results will be expressed as Mean ± SD.
7.3 INVESTIGATION AND INTERVENTIONS
The following biochemical and hematological parameters will be assessed using the following methods:
1. Complete Blood Count by Standard Method.
2. Peripheral Blood Smear by Microscopy.
3. Iron Profile by Ferrozine Iron Method without deproteinization.
4. TIBC by Spectrophotometric Assay
5. Serum Folic Acid levels by Chemiluminescence Automated Assay
6. Blood Glucose by Glucose Oxidase Enzymatic Method.
7. Glycosylated Hemoglobin by Ion Exchange Resin Method.
8. Renal Function Tests ( Blood Urea by GLDH Kinetic ; S.Creatinine by Jaffe’s Kinetic )
9. Urine Routine by Standard Microscopy Method.
10. Stool Microscopy by Standard Method.
7.4 HAS ETHICAL CLEARANCE: YES, CERTIFICATE ENCLOSED.
8. REFERENCES
1. S Sucharita , Ganapathi Bantwal , Jyothi Idiculla , Vageesh Ayyar and Mario Vaz. Autonomic nervous system function in type 2 diabetes using conventional clinical autonomic tests, heart rate and blood pressure variability measures. Indian Journal of Endocrinology and Metabolism. Jul – September 2011; 15(3): 198-203.
2. https://www.unitedhealthfoundation.org/uhfassets/docs/2011/GWU-report-04-2011.pdf.
3. Dhruv K.Singh, Peter Winocour and Ken Farrington. Erythropoietic Stress and Anemia in Diabetes Mellitus. Nature Reviews Endocrinology.2009; 5: 204-210.
4. Merlin C Thomas, Richard J. MacIsaac, Con Tsalamandris, David Power ,George Jerums. Unrecognized Anemia in patients with Diabetes. Diabetes Care. April 2003; 4: 1164 – 1169.
5. Merlin C Thomas. Anemia in Diabetes: marker or mediator of microvasculardisease. Nature Reviews Nephrology. January 2007; 3: 20-30.
6. Katherine J. Craig, John D. Williams, Stephen G.Riley, Hilary Smith, David R.Owens, Debbe Worthing et al. Anemia and Diabetes in the Absence of Nephropathy. Diabetes Care. May 2005; 28(5): 1118-1123.
7. Babatunde Ishola Adejumo, Uchechukwu Dimkpa, Chinwe Obianuju Ewenighi, Abduffatah Adekunle Onifade, Azukaego Thomas Mokogwu, Tosan Amos Erhabor et al. Incidence and Risk of Anemia in type 2 diabetic patients in the absence of renal impairment. Health. 2012; 4(6): 304-308.
8. Janet B Mc Grill, David S.H. Bell. Anemia and the role of erythropoietin in diabetes. Journal of Diabetes and its Complications. July – August 2006; 20 (4): 262- 272.
9. SIGNATURE OF CANDIDATE:
10. REMARKS OF THE GUIDE:
11.NAME AND DESIGNATION OF GUIDE:
Dr. K.J. VEDAVATHI
PROFESSOR OF PHYSIOLOGY
DEPARTMENT OF PHYSIOLOGY
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL
KAMBIPURA, MYSORE ROAD, BANGALORE
KARNATAKA, INDIA.
11.1 NAME AND DESIGNATION OF CO - GUIDE:
DR. KRISHNA
PROFESSOR AND HEAD
DEPARTMENT OF MEDICINE
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL
KAMBIPURA, MYSORE ROAD, BANGALORE
KARNATAKA, INDIA.
11.2 SIGNATURE OF GUIDE:
11.3 SIGNATURE OF CO – GUIDE :
11.4 SIGNATURE OF HOD :
12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL :
12.2 SIGNATURE
ANNEXURE -1
QUESTIONNARE - 1
Part I – Personal and Residential Information
Name :
Age :
Sex :
Marital Status :
Education :
Occupation :
Residential Address : ______
______
______
______
Do you smoke :
Do you consume alcoholic beverages:
Have you used drugs (other than therapeutic) in the past :
Do you chew tobacco :
Were you on any medications :
Are you on any medications :
Since how many years are you a diabetic ?
Do you suffer from Hypertension ?
Do you have any Thyroid Disorders ?
Do you have any Cardiac / Heart Disease ?
Do you suffer from any menstrual disorder ?
If yes, then kindly mention what the problem is ?
Diet History :
Morning:______
______
Afternoon:______
______
Evening:______
______
Night:______
______
QUESTIONNARE - 2
Part II – Medical History
Tick the appropriate boxes for the following symptoms:
· Sudden Weight gain : Yes/No
· Sudden weight loss : Yes/No
· Increased fatigue : Yes/No
· Increased frequency of urination : Yes/No
· Increased appetite/food intake : Yes/No
· Increased Thirst : Yes/No
· Feeling of pins and needles sensation in the extremity : Yes/No
· Flashes in front of eye : Yes/No
· Altered Bowel habits : Yes/No
· Breathlessness : Yes/ No
· Any Other symptoms : Yes/ No
· If yes please describe the symptoms :______
______
· Have you suffered from any major illness or disease in the past :Yes/No
· If yes give details of the disease :______
______
· Do you have any visual disturbances : Yes/No
· Do you have any hearing disability : Yes/No
· Are you on chronic medication for any reason : Yes/No
· Do you suffer from sleep disorders : Yes/No
· Family history of diabetes mellitus :
______
______
______
Have you had any Blood Transfusions in the past ? : Yes / No
If yes, then explain the reason for the blood transfusion : ______
______
When did you have the blood transfusion ? ______
QUESTIONNARE - 3
Part III – Clinical Examination
General Examination :
Height :
Weight :
Body Mass Index :
Waist Hip ratio :
Pallor :
Clubbing :
Cyanosis :
Goitre :
Pulse rate :
Blood Pressure in supine position :
Koilonychia / Platonychia :
Skin Contour :
Knuckle Pigmentation :
Systemic Examination :
Respiratory System :
______
______
Cardiovascular System :
______
______
Per Abdomen :
______
______
Central Nervous System :
______
______
ANNEXURE - 2
Part IV – Investigations
Assessment Measure / ResultsHb
PCV
RBC Count
MCV
MCHC
TC
DC
ESR
Blood Group & Rh Typing
Platelet Count
Reticulocyte Count
S. Ferritin
TIBC
S. Folic Acid
S. Vit B12
Fasting Blood Glucose
Post Prandial Glucose
Fasting Urine Sugar
Post Prandial Urine Sugar
Glycosylated Hemoglobin
Blood Urea
S.Creatinine
Urine Routine
Results of Complete Blood Count :
Results of Peripheral Blood Smear :
Results of Urine Routine :
Quantity, ColourSugar
Albumin
Rbc’s
Epithelial Cells
Pus cells
Casts
Results of Stool Routine :
Quantity, ColourOva & Cysts
Occult Blood
Rbc’s
ANNEXURE - 3
DD / MM / YYYYINI / TIA / LS
CONSENT FORM
STUDY TITLE
“A COMPARATIVE STUDY OF ANAEMIA WITH THE DEGREE OF GLYCAEMIC CONTROL IN TYPE 2 DIABETES MELLITUS”
I have been explained the procedures involved in the study and I have understood that:
1. Personal and medical history will be collected as a part of the study.
2. Certain body measurements such as height, weight, waist and hip will be taken.
3. I will have to give my blood sample, urine sample and stool sample for laboratory investigations.
4. I will not hold the investigator responsible for any complications or side effects that might occur as a result of this study.
4. My involvement in the study is purely voluntary and that I can withdraw from the study whenever I want with no obligations.
5. I will be informed of the test results, on request.
After having read through the procedures involved and after having been given a chance to clear my queries, if any, I volunteer as a subject for the above mentioned study.
Name and signature of investigator Signature of subject
Date: Date