Jawaharlal Institute of Post Graduate Medical Education and Research Puducherry - 605 006

JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL
EDUCATION AND RESEARCH

PUDUCHERRY - 605 006.
An institute of national importance under Ministry of Health & Family Welfare
Government of India.
PROTOCOL
FOR SUBMITTING DISSERTATION TOPICS FOR M.D. / M.S.
DEGREE STUDENTS SESSION 2011 2014.
1.
NAME OF THE CANDIDATE
Dr. THIPPESWAMY .D .N
2.
NAME OF THE COURSE STUDYING
M.D. Biochemistry
3.
YEAR OF ADMISSION
APRIL 2011
4.
MONTH & YEAR OF APPEARING FOR

FINAL EXAMINATION
MARCH 2014
5.
MONTH & YEAR OF SUBMITTING

DISSERTATION
AUGUST 2013
6.
NAME OF THE GUIDE & DESIGNATION :
Dr. P. H. ANANTHANARAYANAN,
Professor and Head,
Department of Biochemistry,
JIPMER, Puducherry.
7.
NAME OF THE CO GUIDE &

DESIGNATION
Dr. R. MANIKANDAN,
Assistant Professor,
Department of Urology,
JIPMER, Puducherry.
8.
TITLE OF THE SUBJECT :

TO INVESTIGATE THE EXISTENCE OF METABOLIC SYNDROME
IN PATIENTS WITH PROSTATE CARCINOMA
(OR)
ADIPONECTIN, LEPTIN, IL-6 (ADIPOKINES) LEVELS AND METABOLIC
SYNDROME IN PATIENTS WITH PROSTATE CA.
9. INTRODUCTION
Prostate cancer is the most frequently diagnosed malignancy in American
men, and is the most common malignancy found among men worldwide. And it is the
second most common cause of death after using cancer.
The prostate, a gland in the male reproductive system, that helps make and
store seminal fluid.
The specific causes of prostate cancer remain unknown, primary risk actors
are age and family history.
Uncommon in men younger than 45, but becomes more common with
advancing age, average age at the time of diagnosis is 70.
Growing evidence on the obesity and the associated pathologies has led to
understand the role of adipose tissue as an active potential participant in
controlling the physiological and pathological processes.
Metabolic syndrome is associated with visceral obesity. It assembles some

abnormalities, including insulin resistance, hyperinsulinemia, hypertension
and dyslipidemia, hyperglycemia all risk factors directly associated with both
type 2 diabetes and cardiovascular disease.
Risk associated with obesity has also been extended to several malignancies.
Its role in PC etiology is less clear.
Data on the association between obesity and prostate cancer incidence are
inconsistent. So, we investigated role of adipokines in prostate carcinoma.
10. AIMS AND OBJECTIVES

AIM :
To study the levels of certain adipokines like adiponectin, IL-6, Leptin and
metabolic syndrome in patients with prostate carcinoma.
OBJECTIVES :
1.
To assess the levels of adiponectin, leptin, IL-6 in patiens with prostate

cancer.
2.
To investigate existence of various components of metabolic syndrome,

in patients of prostate carcinoma.
3.
To study the association (if any) between various parameters studied in

patients with prostate carcinoma.
11. REVIEW OF LITERATURE

Obesity is associated with an array of health problems in adult and paediatric
populations. Understanding the pathogenesis of obesity and its metabolic sequelae
has advanced rapidly over the past decades.
Adipose tissue represents an active endocrine organ that, in addition to
regulating fat mass and nutrient homeostasis, releases a large number of bioactive
mediators (Adipokines) that signal to organs of metabolic importance including brain,
liver, skeletal muscle, and the immune system-there by modulating.
Homeostasis, blood pressure, lipid and glucose metabolism, inflammation and
atherosclerosis, to date, the adipose tissue is considered as an endocrine organ able
to mediate biological effects on metabolism and inflammation, contributing to the
maintenance of energy homeostasis and probably, pathogenesis of obesity-related
metabolic and inflammatory complications and possibly cancers like prostate, breast
etc.
Unlike most other Adipokines, plasma Adiporectin levels were reduced in

animal models of obesity and insulin resistance.
Administration of recombinant adiporectin to rodents resulted in increased

glucose uptake and fat oxidation in muscle, reduced hepatic glucose
production and improved whole. Whole-body insulin sensitivity.
In addition to its insulin-sensitizing effects, adiporection (Anti inflammatory,

anti thrombotic and anti atherogenic properties) may after glucose metabolism
through stimulation of pancreatic insulin secretion in vivo.
In humans, plasma Adiponectin levels were correlated negatively with

adiposity, insulin resistance, type-2 diabetes mellitus and metabolic syndrome
yet positively correlated with markers of insulin sensitivity.
Leptin : Since its identification in 1994, leptin has attracted much attention as
one of the most important signals for the regulation of food intake and energy
homeostasis.
Leptin receptor-mediated JAK-STAT signalling is essential for regulation of

food intake and body weight, leptin-stimulated PI3K signalling appears to be
important for regulation of glucose metabolism. Leptin modulates pancreatic
-cells function through direct actions and indirectly through central neural
pathways.
Insulin stimulates both leptin biosynthesis and secretion from adipose tissue,
establishing a classic endocrine Adipo-insular feed back loop; the so called
Adipo-Insular axis. Leptin serues as a major Adipostat by repressing food
intake and promoting energy expenditure. Independent of these effects, leptin
improves peripheral (hepatic and skeletal muscle) insulin sensitivity and
modulates pancreatic -cell function.
Both TNF- and IL-6, most widely studied cytokines produced by Adipose
tissue, were reported to modulate insulin resistance.
Conflicting data exist regarding the role of IL-6 in insulin resistance.
IL-6 was reported to reduce insulin-dependent hepatic glycogen synthesis a

glucose uptake in Adipocytes.
Persistent systemic increases of IL-6 in states of chronic inflammation such as

obesity, type 2 diabetes mellitus may trigger insulin resistance.
There are a paucity of studies in evaluating the levels of circulating Adipokine

levels a metabolic syndrome in patiens with carcinoma of prostate in South
India. So we propose to study the levels of the fore said Biochemical
parameters in patients with prostate cancer as compared with healthy control
men.
12. WORK ALREADY DONE:
Procedures for estimating insulin and HbA1C have been standardized in

our lab.
Literature search done.
13. MATERIALS AND METHODS

(a)
Whether the study involves

humans, animals or both
Human subjects only
(b)
Type of study
Cross-sectional study
(c)
No. of group to be studied

a) Cases
:
:
2
Men with CA prostate
b) Controls
Healthy age / BMI matched Men.
d)
Sample size in each group
The sample size(67) was calculated by

using the statistical formula for
hypothesis testing of two means.
(e)
(i) INCLUSION CRITERIA

Cases
-
Men with CA prostate.
(ii) EXCLUSION CRITERIA :

For both cases and controls.
(f)
Age <18 years
Chronic infectious diseases
Known case of connective tissue disease like SLE
Chronic renal disease and liver disease.
Drugs used if any
Nil.
(g)
Parameters to be studied
i. Anthropometric parameters :
-
Blood pressure
BMI
Waist circumference
Hip circumference
Waist to hip ratio
ii. Routine biochemical investigations :

-
Blood glucose
Total lipid profile
HbA1C
PSA
Testosterone
Estrogens
iii. Biochemical parameters related to the proposed study

-
Insulin
Adiponectin
IL-6
Leptin
Admission-insulin resitance index (AIRI), fasting insulin resistance index
(FIRI) with be calculated.
BRIEF PROCEDURE :
Ethical clearance will be obtained from the institute ethics committee. The
study protocol will conform to the ethical guidelines of the declaration of Helsinki, and
written informed consent will be obtained from all subjects before participation.
Patients with CA prostate in this study will be recruited from the Department of
Urology, JIPMER, based on inclusion / exclusion criteria already mentioned above,
clinical and anthropometric parameters will be recorded, according to a predesigned
proforma.
Collection of samples :
Blood samples will be drawn from the Antecubital vein following light
application of a tourniquet at admission.
Fasting blood sample will be collected early in morning for estimating fasting
lipid profile, insulin, glucose levels, serum will be separated, stored at -80c for
further analysis of other biochemical parameters, IL-6, leptin, adiporectin levels will
be estimated using commercially available ELISA kits.
PSA, testosterone, estrogen. to be estimated
Insulin levels will be estimate using chemiluminescence in the advia centaur
immuno analyzed.
STATISTICAL ANALYSES :
Both descriptive and inferential statistics will be used to analyze the data. To
present the normally distributed data, mean with standard deviation will be used and
for non-nomrally distributed data, median with interquartile range will be used.
Appropriate parametric (independent students t test) (n) non parametric
(mann-whitney U test) will be used to compare the continuous variables between the
groups.
Chi-square test (n) fishers exact test will be used for comparing categorical
variables between groups.
14. HYPOTHESIS
Prostate CA is associated with decrease in adiponectin and increase IL-6,
leptin levels and is associated with metabolic syndrome.
PLEASE TICK THE FOLLOWING:

Inter/Intra departmental
If Inter-departmental whether consent taken
from concerned department
Any extra equipment or finance required to
carry out the study
If yes, source
a) Self
b) Institution
c) Department
d) Companies
e) Other agencies specify
Whether ethical problems involved
If yes, mention briefly
:
:
Inter departmental
Yes
No
:
:
No
-
SIGNATURE OF THE CANDIDATE

(Dr. PRATIBHA KUMARI)
SIGNATURE OF CO-GUIDE
NAME & DESIGNATION
Dr. R. MANIKANDAN,
Assistant Professor,
JIPMER, Puducherry.
SIGNATURE OF GUIDE
NAME & DESIGNATION
Dr. P. H. ANANTHANARAYANAN,
Professor and Head,
Department of Biochemistry,
JIPMER, Puducherry.
SIGNATURE OF HEAD OF THE

COLLABORATING DEPARTMENT WITH SEAL.
Dr. Santhosh Kumar
Professor and Head,
JIPMER, Puducherry.

Jawaharlal Institute of Post Graduate Medical Education and Research Puducherry - 605 006

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JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL

EDUCATION AND RESEARCH

NAME OF THE CANDIDATE

NAME OF THE COURSE STUDYING

MONTH & YEAR OF APPEARING FOR

MONTH & YEAR OF SUBMITTING

NAME OF THE GUIDE & DESIGNATION :

NAME OF THE CO GUIDE &

TITLE OF THE SUBJECT :

Metabolic syndrome is associated with visceral obesity. It assembles some

Its role in PC etiology is less clear.

10. AIMS AND OBJECTIVES

To assess the levels of adiponectin, leptin, IL-6 in patiens with prostate

To investigate existence of various components of metabolic syndrome,

To study the association (if any) between various parameters studied in

11. REVIEW OF LITERATURE

Unlike most other Adipokines, plasma Adiporectin levels were reduced in

Administration of recombinant adiporectin to rodents resulted in increased

In addition to its insulin-sensitizing effects, adiporection (Anti inflammatory,

In humans, plasma Adiponectin levels were correlated negatively with

Leptin receptor-mediated JAK-STAT signalling is essential for regulation of

Conflicting data exist regarding the role of IL-6 in insulin resistance.

IL-6 was reported to reduce insulin-dependent hepatic glycogen synthesis a

Persistent systemic increases of IL-6 in states of chronic inflammation such as

There are a paucity of studies in evaluating the levels of circulating Adipokine

12. WORK ALREADY DONE:

Procedures for estimating insulin and HbA1C have been standardized in

Literature search done.

13. MATERIALS AND METHODS

Whether the study involves

Human subjects only

No. of group to be studied

Healthy age / BMI matched Men.

Sample size in each group

The sample size(67) was calculated by

(i) INCLUSION CRITERIA

Men with CA prostate.

(ii) EXCLUSION CRITERIA :

Age <18 years

Chronic infectious diseases

Known case of connective tissue disease like SLE

Chronic renal disease and liver disease.

Drugs used if any

Waist to hip ratio

ii. Routine biochemical investigations :

Total lipid profile

iii. Biochemical parameters related to the proposed study

(FIRI) with be calculated.

PLEASE TICK THE FOLLOWING:

SIGNATURE OF THE CANDIDATE

SIGNATURE OF HEAD OF THE

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