Rajiv Gandhi University of Health Sciences Bangalore, Karnataka s39

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

Annexure II

Proforma for Registration of Subject for Dissertation

1. Name of the candidate DR. NEELA B. MANNANGI

Address DEPARTMENT OF BIOCHEMISTRY J.S.S. MEDICAL COLLEGE S.S. NAGAR, BANNIMANTAP, MYSORE – 570 015

2. Name of the institution J.S.S. MEDICAL COLLEGE S.S. NAGAR, BANNIMANTAP, MYSORE – 570 015

3. Course of the study and subject M.D (Biochemistry)

4. Date of admission to course 31-05-2007

5. Title of the Topic

STUDY OF SERUM LIPOPROTEIN(a) AND LIPID PROFILE

IN CHRONIC KIDNEY DISEASE

6. Brief resume of the intended work: 6.1 Need for the study:

Chronic kidney disease refers to an irreversible deterioration in renal function which classically develops over a period of years1. It is studied that patients with Chronic

Kidney Disease have altered levels of Lp(a).2

Lipoprotein (a) (Lp(a)), is a cholesterol rich particle existing in human plasma, was first described by Berg in 1963.2 Many epidemiological and case control studies have showed that, when present in high levels in plasma, Lp(a) is recognized as an independent risk factor for coronary heart disease.2

In renal failure, studies have revealed an increase in plasma concentration of

Lp(a). Elevated plasma Lp(a) levels in chronic renal failure patients have been associated with a frequency distribution of apolipoprotein(a) of [apo(a)] isoforms, similar to those found in general population.2

Lipid abnormalities are one of the important risk factors of atherosclerosis commonly reported in chronic kidney disease. The risk of atherosclerotic cardiovascular disease in end-stage renal disease has been reported to be many times higher than for normal comparable age. One of the important risk factors for atherosclerosis reported in patients of chronic renal failure is hyperlipidemia.3

Several studies have been done to study the levels of Lp(a) in patients with chronic kidney disease.

However very few studies have been conducted to study the correlation between

2 elevated levels of Lp(a) and lipid profile in patients with chronic kidney disease. Hence the present study is taken up to establish the correlation between the elevated levels of Lp(a) and lipid profile in patients with chronic kidney disease.

6. 6.2 Review of literature

Elevated plasma Lp(a) and lipid profile abnormalities in patients with chronic

kidney disease have been studied from various aspects.

Hamid Nasri et.al., have studied serum Lp(a) concentrations with atherosclerotic

vascular changes in pre-dialysis chronic renal failure and maintenance on hemodialysis.

Patients on hemodialysis showed positive relationship of serum Lp(a) with early

atherosclerotic vascular change.2

Shah B et.al, reported reduced HDL cholesterol levels and increased triglycerides

in patients with chronic kidney disease.3

Hamid Nasri et.al., studied relationship of serum Lp(a) with carotid intimae-media

thickness in predialysis chronic renal failure, haemodialysis and kidney transplant patients

and observed positive correlation of Lp(a) levels with intima-media thickness in

haemodialysis patients.4

Leonardo A. Sechi et.al, studied Lp(a) levels in patients with early renal failure

and observed increased serum lipoprotein (a) levels in the study group.5

Ochoa-Sosa et.al, have studied lipoprotein(a) and lipids in chronic renal

3 insufficiency and kidney transplant patients and observed lipoprotein(a) levels were

reduced and cholesterol levels were elevated in renal transplants.6

6.3 Objectives of the study

1. To estimate serum Lp(a) and total cholesterol, HDL-cholesterol, LDL-cholesterol

and triglyceride levels in chronic kidney disease.

2. To compare serum Lp(a) and total cholesterol, HDL-cholesterol, LDL-cholesterol

and triglyceride levels in both chronic kidney disease and healthy volunteers.

3. To find if there is any correlation between serum Lp(a) and total cholesterol, HDL

cholesterol, LDL-cholesterol and triglyceride levels in the study group.

7. Materials and methods

7.1 Source of data

Diagnosed chronic kidney disease patients from Nephrology department of J.S.S

Medical College and Hospital, Mysore

Exclusion criteria:

 Patients who reported cigarette smoking, recent MI and vascular diseases.

 Patients taking anti-lipid drugs.

Inclusion criteria:

These include diagnosed cases of chronic kidney disease from Nephrology

department of J.S.S. Medical College and Hospital, Mysore.

7.2 Method of data collection

The sample size consists of 30 chronic kidney disease diagnosed patients from the

4 Nephrology department of J.S.S Medical College and Hospital, Mysore and 30 healthy controls, both groups age and sex matched.

Statistical methods to be employed

 Analysis has been done on the basis of mean values, standard deviation,

standard errors and the ‘t’-test.

 Test of significance

 PEARSONS – correlation -coefficient

All the above mentioned statistical methods will be performed through software –

SPSS (statistical presentation systems software) for windows

7.3 Does the study require any investigations or interventions to be conducted on patients or other human or animals? If so, please describe briefly;

Yes, venous blood samples collected aseptically and sent from Nephrology department after obtaining consent will be estimated for serum Lp(a) levels and serum lipid profile. Venous blood will also be collected aseptically from healthy volunteers for estimation of the same after obtaining due consent.

The methodologies for the above are mentioned below.

 Serum Lp(a) will be estimated by Immunoturbidimetric method.7

 Serum total cholesterol will be estimated by Enzymatic Endpoint Method.8

 Serum triglycerides will be estimated by GPO-PAP method.8

 Serum HDL will be estimated by Enzymatic End point Method.8

 Serum LDL will be estimated by using Friedewald equation.8

5 Friedewald equation

[LDL – cholesterol] = [total cholesterol] – [HDL cholesterol] – (triglycerides ) 5 7.4 Has ethical clearance been obtained from your institution in case 7.3?

8. List of references

1. J. Goodard, A.N. Turner, A.D Cumming, L.H Stewart. Kidney and urinary tract

disease in; Medicine Davidson’s textbook. Nicholas A.Boon, Nick. R. Colledge,

Brain R. Walker, Editors, 20th edition, 2004; 185-490.

6 2. Hamid Nasri, A Baradaran. Relationship of serum lipoprotein (a) with carotid

intimaemedia thickness in predialysis chronic renal failure, haemodialysis and

kidney transplant patients. Shiraz E-Medical Journal 2004; 5(3):224-371.

3. Shah b, Nair S, Sirsat RA, A Sharid TF, Nair K. Dyslipidemia in patients with

chronic renal failure and in renal transplant patients. Journal of Postgraduate

Medicine 1994; 40(2): 57-60.

4. Hamid Nasri, Azar Baradaran. Relationship of early atherosclerosic vascular

change with serum lipoprotein(a) predialysis chronic renal failure and

maintenance hemodialysis patients. Turkish Journal of Endocrinology and

Metabolism 2003; 7(4):1-6.

5. Leonardo A Sechi, Laura Zingaro, Stefgano de Carli, Giovanni Sechi, Cristiana

catena, Edmondo Falleti, Elisabetta Dell Anna, Ettore Bartoli. Increased serum

lipoprotein(a) levels in patients with early renal failure. Ann Intern Med 1998;

129(5):457-461.

6. Ochoa-Sosa CA, Mondragon-Rodriguez G, Zamora-Gonzalez J, Cardoso-Saldana

G, Herrera –A Costa J, Posadas – Romero C. Lipoportein(a) and lipids in chronic

renal insufficient and kidney transplant. Rev Invest Clin. 1998; 50(4):301-306.

7 Pmid:9830317 [pubmed-indexed for medline]

7. Nader Rifai, Paul S Bachorik, John J Albers, Carbohydrates in; Teitz textbook of

clinical chemistry. Carl a Burtes, Edward R Ashwood, David E Burns, Editors, 5th

edition, Philadelphia, W.B Saunders. 2006; 427-459.

8. Nader Rifai, Paul S Bachorik, John J Albers, Lipids, lipoproteins, apolioproteins

in; Teitz textbook of clinical chemistry. Carl a Burtes, Edward R Ashwood, David

E Burns, Editors, 4th edition, Philadelphia, W.B Saunders. 2006; 462-493.

9. Signature of Candidate

10. Remarks of the guide This study helps in the better management of patients with Chronic Kidney Disease

8 11. 11.1 Name and designation of the Dr. H.S Virupaksha M.D, FIAMS

guide Professor and HOD Department of Biochemistry J.S.S. Medical College and Hospital Mysore – 570 015

11.2 Signature 11.3 Co-guide

11.4 Signature

11.5 Head of the Department Dr. H.S Virupaksha M.D, FIAMS Professor and HOD Department of Biochemistry J.S.S. Medical College & Hospital Mysore – 570 015

11.6 Signature 12. 12.1 Remarks of the Chairman and Principal

12.2 Signature