18100006005 THESIS
TITLE:
“ESTIMATED GLOMERULAR FILTRATION RATE AS A MARKER FOR EARLY DETECTION OF CHRONIC KIDNEY DISEASE IN TYPE 2 DIABETES MELLITUS”
INTRODUCTION:
Diabetes is major health issue that has reached alarming levels ,today nearly half billion people are living with diabetes worldwide.
DEFINITION:
Diabetes is chronic condition that occurs when there are raised levels of glucose in blood either because of decreased insulin secretion (Type 1) or resistance to insulin action (Type 2) or combination of both.
Table- 1 Modified diagnostic criteria for diabetes
The World Health Organization estimated that there were 463 million diabetics in 2019 and this number would increase to 578 million by the year 2030 and 700 million by 2045. India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “Diabetes capital of the world”. (1) According to the Diabetes Atlas 2017 published by the International Diabetes Federation, the number of people with diabetes in India currently around 72.9 million is expected to rise to 134.3 million by 20453. Diabetic nephropathy is one of the leading causes of chronic renal failure in India.
DIABETIC RETINOPATHY:
In India, the previous studies to calculate prevalence were by Raman et al. (18.1%) (4), Rema et al. (17.%) (5) , Namperumalsamy et al. (10.6%) (6) , Narendran et al. (26.2%) (7) and Dandona et al (8) . The prevalence in the AIOS study was 21.27% with a range of 12.27% in the central zone and 34.06% in the north zone.
PERIPHERAL VASCULAR DISEASE:
Prevalence of PAD in T2D patients in Delhi, North India, is much lower than that reported in western population (∼20%) and from south India (6.3%). Prevalence of PAD was higher in patients with higher age, longer duration of diabetes, lower BMI, and higher total and LDL cholesterol (9).
CORONARY ARTERIAL DISEASE:
The prevalence of CAD in the CUPS study was 11% in the total population, with 1.2% patients having had a MI, 1.3% with Q-wave changes, 1.5% with ST-segment changes, and 7.0% with T-wave abnormalities (10,11). This 11% represents a 10-fold increase in CAD prevalence in urban India since 1970 (10,12), now approaching those reported in migrant Indians. In the same study, the prevalence of CAD among diabetic subjects was 21.4% (known diabetes, 25.3%, and newly diagnosed diabetes, 13.1%), which was much higher than the figure of 14.9% among subjects with IGT and 9.1% among those with NGT. Prevalence of known MI was three times higher in diabetic subjects.
DIABETIC NEPHROPATHY:
A study was performed to evaluate the various etiologies of CKD among patients presenting to the Department of Nephrology, Guwahati Medical College, a tertiary referral center. A total of 5718 CKD patients were evaluated to identify the cause of CKD. The most common cause was found to be diabetes mellitus in 42.2%, followed by chronic glomerulonephritis in 21.4%, hypertension in 19.5%, obstructive uropathy in 6.9%, chronic interstitial nephritis in 3.6%, and autosomal dominant polycystic kidney disease in 1.5% of the patients. Nearly 2.7% of the patients had CKD of unknown etiology (13) .
EFFECT OF SOCIOECONOMIC STATUS
Prevalence of diabetes was found to be lower in low socioeconomic group living in urban areas compared with the high income group . This was probably related to the physical activity of the low income group as most of them were involved in moderate to strenuous physical activity . However long term complications like CAD , CKD , PAD and diabetic retinopathy are more common in low socioeconomic group because of uncontrolled blood sugars , alcohol and smoking .
FIGURE- 1 Recent population based studies showing the prevalence of type 2 diabetes in different parts of India
ECONOMIC BURDEN OF DIABETES IN INDIA
A recent study showed that in India , the total expenditure on diabetes care was , on average Rs.10,000 in urban areas and Rs.6260 in rural areas . A study conducted in 2008 and 2009 found that total cost for patients without complications were Rs.4493 compared to Rs.14,692 for patients with complications (14) .
FIGURE- 2 Estimated number of diabetic subjects in India
DIABETIC NEPHROPATHY:
Diabetic nephropathy is a serious kidney related complication seen in patients with diabetes. Patients usually manifest with clinical syndrome of DN which includes persistent proteinuria, hypertension, and progressive decline in renal function with or without retinopathy leading to end stage renal disease (ESRD). Patients with diabetic nephropathy are also at increased risk of premature cardiovascular problems, CVA, peripheral neuropathy and diabetic retinopathy. The development of proteinuria begins as microalbuminuria (albumin excretion rate 2 – 200 micrograms per minute) is typically seen 5 – 15 years after diagnosis of diabetes and associated raise in blood pressure. Microalbuminuria gradually progresses to macroalbuminuria (AER more than 200 micrograms per minute ) at which blood pressure is elevated and other micro and macro vasuclar complications emerge and from this point there is a decline in GFR in a linear fashion and , with no intervention , a fall of approximately 10ml/min/year leads to ESRD within 10 years . All these complications influence the quality of life and cause economic burden. Thus there is an increasing focus on detecting the diabetic nephropathy in early stages by routine clinical examination and routine estimation of GFR by MDRD equation and screening for microalbuminuria in all diabetic patients. Considering all the above mentioned issues, this study was conducted in Department of General medicine, Kamineni Institute of Medical Sciences , Narketpally in both inpatients and outpatients for early detection of CKD in patients with type 2 diabetes based on eGFR estimation with the help of MDRD formula and staging based on KDOQI .
AIM OF THE STUDY:
To analyze estimated glomerular filtration rate as a marker in early detection of chronic kidney disease in type 2 diabetes mellitus.
OBJECTIVES OF THE STUDY:
To calculate estimated glomerular filtration rate in type 2 diabetes mellitus patients and categorize patients into different stages of CKD .
To calculate urine albumin /creatinine ratio to stage kidney damage.
To determine kidney damage based on eGFR and urine albumin /creatinine ratio.
METHODOLOGY:
PATIENTS AND METHODS:
STUDY DESIGN : Single centre non randomized Cross sectional study
STUDY SETTING : All type 2 diabetes mellitus patients in out patients and inpatients admitted in Department of General Medicine, Kamineni institute of medical Sciences , Narketpally.
STUDY DURATION : OCTOBER 2018 - SEPTEMBER 2020
SAMPLE SIZE : Type2 Diabetes Mellitus – 100 Patients
ETHICAL COMMITTEE APPROVAL : Obtained
PATIENT CONSENT : Informed consent was obtained
FINANCIAL SUPPORT : Nil
CONFLICT OF INTEREST : Nil
Collaborating Departments:
- Department of General Medicine ;Kamineni Institute of Medical Sciences.
- Department of Biochemistry ; Kamineni Institute of Medical Science
Selection of study subjects :
During the period of study 227 type 2 diabetic individuals (both inpatients and outpatients) were evaluated. Out of these 50 patients were excluded due to usage of ACE or ARB‟s, 7 patients were excluded because of urinary tract infection, 40 patients were excluded due to elevated serum creatinine >2mg/dl, 30 patients were excluded due to macroalbuminuria. After excluding 127 patients, 100 patients were left in the study group and were evaluated. Data was collected in a cross sectional way.
- Patients were initially screened with early morning urine for spot protein creatinine ratio and then based on absence of macro proteinuria by 24hr urinary protein. The test was repeated 3 times and a average of 3 was taken as absence of significant proteinuria.
- Fundus was studied with direct ophthalmoscope and assessed for retinopathy.
- Blood pressure was measured with mercury manometer and average of 6 blood pressure recordings were taken for analysis.
- Serum creatinine and blood glucose were analyzed using ERB full auto analyzer.
- Hemoglobin was estimated using coulter counter.
- Urine protein was analyzed using auto analyzer.
- Data was analyzed with MINITAB 15 statistical soft ware.
- Cross tabulation and chi square analysis was done using the variables recorded.
- eGFR was calculated using MDRD formula.
INCLUSION CRITERIA:
1 Patients who are 40 years of age or older and completed a standardized interview and a detailed physical examination and classified as having type2 DM according to the American Diabetes Association (ADA).
2 Serum creatinine <2.0 mg.
EXCLUSION CRITERIA:
1. Patients who are not willing for the study are excluded
2. Patients known to be microalbuminuric before antihypertensive therapy was started are not eligible for this study
3. Those who were/are on Angiotensin converting enzyme inhibitors / Angiotensin receptor blockers are excluded
4. Patients with
• urinary tract infection,
• congestive heart failure
• Malignant hypertension
• Accelerated hypertension
All the subjects in the study group were enquired about the following :
Polyuria , polydipsia , polyphagia , weight loss, chest pain, palpitations, breathlessness, pedal edema, facial puffiness, dysuria, oliguria, hematuria, pins and needles burning sensation in extremities, foot infection, amputation, diminution of vision, acute complications like DKA, hypoglycemia, hyperosmolar state, CVA, MI.
Autonomic features like absence sweating, postural giddiness, chronic diarrhea, constipation.
Any history of macrovascular complications like MI, hypertension, peripheral vascular disease, retinopathy, alcohol consumption, smoking, intake of ACEI OR ARB‟S medication .
EXAMINATION:
Height
Weight
Waist circumference
Body Mass Index (BMI)
Pulse and peripheral pulses
Blood pressure ( mean of 6 readings )
TABLE-4 Staging of blood pressure according to 2020 International Society of Hypertension Global Hypertension Practice Guidelines:
Postural drop of blood pressure
Retinopathy
Normal fundus
Non proliferative diabetic retinopathy
Proliferative diabetic retinopathy
Investigations :
Complete blood picture
Complete urine examination
urine albumin/creatinine ratio
Blood Glucose - Fasting blood sugar, Post lunch blood sugar, HbA1c
Blood urea : Serum creatinine: Serum electrolytes:
Fasting Lipid profile
Urine spot protein creatinine ratio
24 hrs urinary protein
MASTER CHART:
LINK TO COMPLETE THESIS WITH MASTER CHART:
https://drive.google.com/file/d/15ipE7V0Y88BHRL-z92a1HVFvriRx78Np/view?usp=drivesdk
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