RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. Name of the candidate and address :
ANKUR TALWAR
ROOM NO. 108, KIMS MENS HOSTEL ,
BANASHANKARI –STAGE 2,
BANGALORE - 70
2. Name of the institution :
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES ,
BANGALORE 560070
3. Course of the study and subject :
M.D. IN DERMATOLOGY, VENEROLOGY , AND
LEPROLOGY
4. Date of admission to the course: 1ST MAY 2008
5. Title of the topic :
A CLINICAL AND EPIDEMIOLOGICAL STUDY OF
PATIENTS WITH PSORIASIS AND ITS ASSOCIATION WITH VARIOUS
BIOCHEMICAL PARAMETERS IN NEWLY DIAGNOSED CASES.
6. Brief resume of the intended work :
6.1 NEED FOR THE STUDY
Enclosed
6.2 REVIEW OF LITERATURE
Enclosed
6.3 OBJECTIVES OF THE STUDY
Enclosed
7. Materials and methods :
7.1 SOURCE OF DATA
Enclosed
7.2 METHODS OF COLLECTION OF DATA
Enclosed
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS ? IF SO , DESCRIBE BRIEFLY.
Enclosed
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3
Enclosed
8. List of references :
Enclosed
9. Signature of the candidate :
10. Remarks of the guide :
Psoriasis is one of the most emotionally devastating dermatological disorder.
The present study is undertaken to know more about the epidemiological and clinical
profile of the disease and to assess its association with deranged lipid profile and diabetes
status which in turn act as risk factors for cardiovascular disease in these patients. Further
the co relation of the disease activity with uric acid levels is assessed.
11. Name and designation of the
11.1 GUIDE : DR. M.G. GOPAL
Professor and Head,
Department of Dermatology,
Kempegowda Institute of Medical Sciences.
Bangalore .
11.2 Signature :
11.3 CO – GUIDE : Dr. B.V. RAVI
Associate Professor
Department of Biochemistry,
Kempegowda Institute of Medical Sciences.
Bangalore .
11.4 Signature :
12.1 Remarks of the chairman and principal:
12.2 Signature
6.0 BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
The etiology of psoriasis is unknown but genetic, metabolic, and immunologic mechanisms have
been proposed.The loss of scale observed from the surface from the lesions in the course of the
disease may be related to lipid disorders in epidermis and in the serum1.
Studies have demonstrated that patients with psoriasis may have an increased risk of non
cutaneous diseases , including arterial and venous occlusive diseases. Changes in the plasma
lipid composition may be the reason for increased risk of atherosclerosis in psoriasis2.Early
detection of such abnormalities may result in cutdown in the number of cardiovascular accidents
in psoriasis patients.
It has been suggested that psoriasis is associated with metabolic syndrome, but there have been
very few studies on the association between diabetes and psoriasis. This association is very
important as diabetes is an independent risk factor for the development of cardiovascular
disease3. Dermatologists taking care of patients with psoriasis should be aware of this
association and advise the patients to reduce additional risk factors such as smoking4. Further
the development of certain side effects following systemic therapy are much more common in
diabetics as compared the general population so caution must be exercised in such subjects5.
Elevated uric acid serum levels are a frequent finding in psoriasis It seems a convincing idea that
the rapid epidermal turnover in psoriasis might lead to an increased purine breakdown and may
thus influence the uric acid serum levels6. Consequently, a relationship might well be expected
between hyperuricemia and the extent of psoriatic skin involvement. The present study was
undertaken in order to prove or disprove such an assumption.
6.2 REVIEW OF LITERATURE
Psoriasis is a common and recurrent inflammatory skin disease that can occur due to
abnormalities in essential fatty acid metabolism, lymphokine secretion , free radical generation
,lipid peroxidation and eicosanoid metabolism and has been associated with an increased
frequency of cardiovascular events. Abnormalities in the lipid metabolism have been considered
to play an important role in the pathogenesis of psoriasis and the associated increased risk of
cardoivasular events7.
Alterations in the plasma lipid and lipoprotein composition including a tendency towards an
increase in the total cholesterol (TC) , triglyceride (TG), low density lipoprotein cholesterol
psoriasis may be associated with the disorders of lipid metabolism.
Evidence suggests that chronic inflammation, a characteristic feature of psoriasis, per se may
play a role in the initiation and progress of dyslipidemia and atherosclerosis.
Psoriasis is associated with a wide array of other cutaneous and systemic manifestations. These
represent complications of the accompanying systemic inflammation and are likely to be
mediated through the mechanism of insulin resistance8. As psoriasis is a risk factor for
cardiovascular diseases, its adequate management must include the treatment of other known risk
factors.
Modest hyperuricemia has been found in patients with psoriasis 9 and may be attributed to
enhanced epidermopoeisis with increased epidermal turn over time. More severe forms of uric
acid disbolism lead to aggravated skin affections (psoriatic erythrodermia, exudative
psoriasis),arthritis, occur in familial predisposition to psoriasis1.
6.3 OBJECTIVES OF THE STUDY
1. To assess the clinical pattern of psoriasis.
2. To describe the epidemiological profile of psoriasis.
3. To determine the serum lipid disturbances in newly diagnosed patients of psoriasis.
4. To find out the prevalence of diabetes in newly diagnosed patients of psoriasis.
5. To determine the levels of uric acid in patients with psoriasis and assess the correlation, if
any with the disease activity.
7.0 MATERIALS AND METHODS
7.1 SOURCE OF DATA
The study will comprise the cases of psoriasis visiting the inpatient and outpatient Department of
Dermatology of Kempegowda Institute of Medical Sciences , Bangalore.
METHODOLOGY AND TYPE OF DATA COLLECTED
After obtaining clearance and approval from the institutional ethical committee, a minimum of
30 consecutive cases will be included for the study. After obtaining written informed consent ,
the study subjects will be subjected to detailed history taking including demographic data , drug
history , personal history , family history present and past medical history and history of
emotional stress ,exposure to STD , and drug intake. The available case records will be
scrutinized to collect any valid data. Relevant laboratory investigations to diagnose any any
underlying disease states and other organ/system involvement will be done.A biopsy will be
done in doubtful cases after obtaining a written consent from the patient.
INCLUSION CRITERION
All clinically diagnosed new cases of psoriasis in the age group of 18 – 75 years.
EXCLUSION CRITERION
Patients not willing to take part in the study or unwilling to give their written consent for the
study.
Patients with a past history of systemic or topical treatment for psoriasis.
Patients taking systemic drugs that are likely to interfere with the lipid profile or sugar profile or
serum uric acid levels.
SAMPLE SIZE
A minimum of 30 cases will be investigated
STUDY DURATION
January 2009 to June 2010 (18 months)
STUDY DESIGN
DESCRIPITIVE STUDY
SAMPLE DESIGN
PURPOSIVE SAMPLING
METHODOLOGY
The data for the study will be collected from all those who fulfill the inclusion and the exclusion
criterion on a purposive sampling using a pretested structured questionnaire basis by obtaining a
written informed consent.
STATISTICAL ANALYSIS
The data collected will be analysed statistically by computing descriptive statistics namely mean,
standard deviation, range, chi square test .Wherever necessary the results will be depicted in the
form of graphs and percentages.
7.2 METHOD OF COLLECTION OF DATA
SPECIMEN COLLECTION
Blood :- 5 ml plain venous blood after overnight fasting will be obtained by venepuncture. This
will be followed by centrifugation and then sample will be processed immediately after
collection.
Determinations :-
1. Plasma glucose will be tested by glucose oxidase method.
2. Serum total cholesterol will be estimated by enzymatic method.
3. Serum triglyceride (S.TG) will be determined by enzymatic method.
4. Serum HDL Cholesterol (S.HDL-Ch) will be estimated by phosphotungsate method.
5. Serum VLDL cholesterol is calculated by the formula VLDL = S.TG/5
6. Serum LDL cholesterol will be measured by Friedwald equation if less than 400 mg/dl or
by direct enzymatic method if greater than 400 mg/dl.
7. Total Ch/HDL and LDL-C / HDL-C ratio will be determined.
8. Serum uric acid will be evaluated by the peroxidase/uricase method.
Other investigations :
1. Hb , TC , DC , Peripheral smear.
2. Biopsy wherever required.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO
PLEASE DESCRIBE BRIEFLY.
Study does not include any animal experiments. The following investigations will be carried out
in psoriatic cases only after taking written informed consent.
1. Plasma glucose
2. Lipid profile
Total cholesterol
Triglyceride
HDL Cholesterol
LDL Cholesteol
VLDL Cholesterol
Total Cholesterol / HDL –C ratio
LDL – C / HDL – C ratio
3. Serum uric acid
4. Biopsy will be done in selected cases
8.0 LIST OF REFERENCES
1. Javidi Z,Meibodi NT,Nahidi Y.Serum lipid abnormalities and psoriasis.Indian Journal of Dermatology 2007;52:89-92.
2. Seckin D,Tokgozoglu L,Akkaya S.Are lipoprotein profile and lipoprotein a levels altered in men with psoriasis?J Am Acad Dermatol 1994;31:445-449
3. Kaye JA, Li L, Jick SS. Incidence of risk factors for myocardial infarction and other vascular diseases in patients with psoriasis. : Br J Dermatol. 2008 Sep;159(4):895-902
4. Cohen AD, Dreiher J, Shapiro Y, Vidavsky L, Vardy DA, Davidovici B, Meyerovitch J. Psoriasis and diabetes: a population-based cross-sectional study. J Eur Acad Dermatol Venereol. 2008 May;22(5):585-9.
5. RosenbergPeter ; UrwitzHanna ; JohannessonAnders ; Rosanne-Marie ; LindholmJohan ; KinnmanNils ; HultcrantzRolf . Psoriasis patients with diabetes type 2 are at high risk of developing liver fibrosis during methotrexate treatment . Journal of hepatology 2007,vol.46,pp.1111-1118.
6. Brenner W, Gschnait F. Serum uric acid levels in untreated and PUVA-treated patients with psoriasis. Acta Derm Venereol Suppl (Stockh). 1979;87:41-2.
7. M Akhyani, AH Ehsani, RM Robati, AM Robati. The lipid profile in psoriasis: a controlled study. J Eur Acad Dermatol Venereol 2007,21, 1330–1332.
8. Boehncke WH, Boehncke S. Research in practice: the systemic aspects of psoriasis. J Dtsch Dermatol Ges. 2008 Aug;6(8):622-5.
9. KC Verma, NC Bhargava. Psoriasis - a Clinical and Some Biochemical Investigative Study. Indian Journal of Dermatology. 1979 ;45( 2): 95—99.
10. GolovKG, Ivanov OL, Balkarov IM, Novoselov VS. Clinical significance of hyperuricemia in psoriasis. Klin Med (Mosk). 1994;72(3):34-6.