1

SUMANDEEP VIDYAPEETH

Deemed to be university U/S 3 of UGC act 1956.

SYNOPSIS ON

“EVALUATION OF SERUM AMYLASE AND

SERUM LIPASE AS BIOCHEMICAL MARKERS

OF PANCREATIC EXOCRINE FUNCTION IN

TYPE II DIABETES MELLITUS”

DR. AARSH RAJESH SHAH

1st Year Resident,

Department of General Medicine,

SBKS Medical Institute and Research Center,

Pipariya, Vadodara 391760.

PG Guide:

DR. HETAL PANDYA, M.D.

Professor and Head,

Department of General Medicine,

SBKS Medical Institute and Research Center,

Pipariya, Vadodara 391760

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To

The HRRP Committee,

Smt. B K Shah Medical Institute and Research Centre,

Sumandeep University,

Pipariya, Vadodara.

Date: 09/09/2019

Subject: Submission of Synopsis of Dissertation for M.D General Medicine.

Respected sir/madam,

I, Dr. AARSH RAJESH SHAH, am First year P.G Resident in Department of Medicine,

SBKSMIRC, Pipariya, Vadodara. My topic for dissertation is “EVALUATION OF SERUM

AMYLASE AND SERUM LIPASE AS BIOCHEMICAL MARKERS OF PANCREATIC

EXOCRINE FUNCTION IN TYPE II DIABETES MELLITUS.” I am submitting hard copy

and a soft copy of synopsis of my dissertation.

Kindly accept my submission.

Thanking you,

Sincerely,

Dr. AARSH RAJESH SHAH

3

To,

The Member Secretary,

Sumandeep Vidyapeeth Institutional Ethics Committee,

Smt. B K Shah Medical Institute and Research Centre,

Sumandeep University,

Pipariya, Vadodara.

Date: 09/09/2019

Subject: Submission of Synopsis of Dissertation for M.D General Medicine.

Respected sir/madam,

I, Dr. AARSH RAJESH SHAH, am First year P.G Resident in Department of General Medicine,

SBKSMIRC, Pipariya, Vadodara. My topic for dissertation is “EVALUATION OF SERUM

AMYLASE AND SERUM LIPASE AS BIOCHEMICAL MARKERS OF PANCREATIC

EXOCRINE FUNCTION IN TYPE II DIABETES MELLITUS.” I am submitting hard copy

and a soft copy of synopsis of my dissertation.

Kindly accept my submission.

Thanking you,

Sincerely,

Dr. AARSH RAJESH SHAH

4

Sr. INDEX Page no

1 Introduction

5

2 Key Words

6

3 Aims & Objectives

7

4 Review of Literature

8

5 Methodology

15

6 Benefit & likely outcome of study

18

7 Ethical issues

19

8 Feasibility issue

19

9 Proforma

20

10 References

22

11 Participant information sheet

24

12 Informed consent form 31

5

INTRODUCTION

The prevalence of diabetes mellitus (DM) is developing rapidly and expected to double globally

from 171 million in 2000 to 366 million in 2030 with a maximum rise in India. It is expected that

DM may affect up to 79.4 million individuals in India by 2030[1]. Biochemical cause of DM in

type 1 and type 2 is decreased or lack of insulin secretion and resistance to insulin action

respectively. Insulin is secreted by islets cell of the pancreas. Pancreas is both an endocrine and

an exocrine gland with clusters of endocrinal islet cells dispersed among exocrinal acinar cells[2].

Acinar cells and islet cells are in close proximity with each other. Defect in islet cells observed in

diabetes may disturb neighbouring acinar cells of the pancreas[3].

Enzymes which are released from pancreas are amylase, lipase and proteases[4]. Insulin binds

with its receptor on acinar cells and stimulates amylase secretion through number of ways[5].

Besides these putative mechanisms, there are multiple defects in the insulin secretion and the

signaling in type 2 diabetes, which may affect the enzyme synthesis and release in the exocrine

pancreas. Not only this, also, the secretion of the pancreatic juice is controlled by the autonomic

nervous system and by the naturally occurring gut hormones, cholecystokinin and secretin. This

complex interplay is often found to be disturbed in diabetes due to the well-known complications

of autonomic neuropathy and the microvascular complications, which are so common in

Diabetes mellitus. Defects in insulin secretion and function leads to hyperglycaemia and may

affect the enzyme synthesis and release from exocrine pancreas. High value of amylase and

lipase enzyme is seen in pancreatitis, pancreatic cancer and pancreatic duct obstruction[6].

Recently some studies showed that low serum amylase and lipase values are associated with

metabolic syndrome and diabetes[7,8].

Even though exocrine-endocrine relationship in the pancreas has been a center of attention in

animal and cellular studies, in the human diabetic research, very little concern on pancreatic

exocrine function has been paid. Most of the studies are targeted on metabolic derangement

induced by persistent hyperglycemia due to decreased insulin levels. Animal and cellular studies

showing the relationship between the endocrine and the exocrine pancreas have persistently

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observed that insulin affects amylase secretion via islet acinar cell axis. There are confusing

results regarding serum lipase levels in DM.

Very few studies have been conducted comparing the exocrine functioning of pancreas in

patients of type II diabetes mellitus. Thus there is need for more extensive studies to assess the

role of serum amylase and lipase levels as biochemical markers for pancreatic exocrine function.

KEY WORDS

1) Serum Amylase levels.

2) Serum Lipase levels.

3) Type II Diabetes Mellitus.

4) Endocrine – exocrine axis of pancreas.

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AIM

“TO EVALUATE SERUM AMYLASE AND SERUM LIPASE AS

BIOCHEMICAL MARKERS OF PANCREATIC EXOCRINE FUNCTION IN

TYPE II DIABETES MELLITUS.”

OBJECTIVE

1) To compare Serum Amylase and Lipase levels in type II diabetic patients

with non-diabetic individuals.

2) To study prevalence of exocrine dysfunction (as per abnormal serum

Amylase and Lipase levels) in patients of type II diabetes mellitus compared

to that in non-diabetic individuals.

3) To co-relate the levels of amylase and lipase with the duration of diabetes

and with current glycemic control (HbA1c).

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REVIEW OF LITERATURE

DIABETES MELLITUS

Diabetes mellitus is characterized by chronic hyperglycemia with disturbances of carbohydrate,

fat, and protein metabolism resulting from defects in insulin secretion, insulin action or both.

When fully expressed, diabetes is characterized by fasting hyperglycemia, but the disease can

also be recognized during less overt stages, most usually by presence of glucose intolerance.

ENDOCRINE PART OF PANCREAS, ITS HORMONES AND THEIR

FUNCTIONS [9]

• Alpha cells that produce glucagon and make up 15–20% of total islet cells. Glucagon is a

hormone that raises blood glucose levels by stimulating the liver to convert its glycogen

into glucose.

• Beta cells that produce insulin and amylin and make up 65–80% of the total islet cells.

Insulin lowers blood glucose levels by stimulating cells to take up glucose out of the blood

stream. Amylin slows gastric emptying, preventing spikes in blood glucose levels.

• Delta cells that produce somatostatin and make up 3–10% of the total islet cells.

Somatostatin is a hormone that suppresses the release of the other hormones made in the

pancreas.

• Gamma cells that produce pancreatic polypeptide and make up 3–5% of the total islet

cells. Pancreatic polypeptide regulates both the endocrine and exocrine pancreatic

secretions.

• Epsilon cells that produce ghrelin and make up less than 1% of the total islet cells. Ghrelin

is a protein that stimulates hunger.

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EXOCRINE PART OF PANCREAS, ITS ENZYMES AND THEIR

FUNCTIONS

PROTEASES

• Chymotrypsinogen and Trypsinogen → digest proteins and peptides to single amino

acids.

PANCREATIC LIPASE → digests triglycerides, monoglyceride and free fatty acids

AMYLASE → digests starch and maltose (disaccharides)

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EXOCRINE-ENDOCRINE AXIS OF PANCREAS [10]

Prominent changes in the structure and functions of the exocrine pancreas have been identified in

a sizable number of the commoner forms of diabetes, who are usually not expected to have

exocrine insufficiency. Studies have shown changes in the size of zymogen granules, loss of

acinar cells, acinar fibrosis and pancreatic atrophy in both Type 1 and Type 2 diabetes. Exocrine

Pancreatic Insufficiency [EPI] has also been documented in some forms of Maturity Onset

Diabetes in Young [MODY], namely MODY 3, MODY 5, MODY 8.

Although pancreas has traditionally been considered as two separate organ systems, both the

exocrine and endocrine portions are interrelated. Within the pancreas the exocrine parenchyma

and endocrine islet tissue lie in intimate contact with each other and are anatomically and

physiologically interconnected. This is partly due to the fact that pancreatic islets are not

surrounded by any capsule/ membrane and acinar tissue of the pancreas lies in close contact with

these islets. The capillary plexuses arising of major feeding arteries supply the islets and acini

separately. But the outflow of blood from the islets drains into acinar capillary network. So, the

exocrine pancreas receives at least a part of its blood flow coming through the nearby islets

which forms the so called “insulo-acinar axis”; as a result acinar cells are exposed to high

concentration of islet hormones. Such intrapancreatic portal system suggests a possible influence

of endocrine islets upon the exocrine pancreas.

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WHY SERUM AMYLASE AND LIPASE IN DIABETES ?[11]

Exocrine pancreatic insufficiency (EPI) is defined by a deficiency of exocrine

pancreatic enzymes resulting in an inability to maintain normal digestion. This

inadequate digestion with nutrient and, especially, fat malabsorption occurs when

intraduodenal levels of lipase fall below 5–10% of normal enzyme output, leading

to pancreatic steatorrhea, weight loss, and a potential decrease in quality of life. Fat

maldigestion is compounded by decreased pancreatic secretion of lipase and

colipase, further dampening hydrolysis of intraluminal fat.

On the other hand, Some studies also showed that there is increase in enzyme

levels indicating inflammatory damage to exocrine pancreas.

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REVIEW OF PREVIOUS RESEARCH

In a case control study[12] conducted at Dhaka Medical College, Dhaka, Bangladesh

by Tanvi NEJ, Akhter QS et al in 2015 to know whether impaired pancreatic

endocrine activity in diabetes mellitus affects its exocrine function by assessing

serum amylase and lipase levels in subjects with type II diabetes mellitus. Fifty

type 2 diabetic subjects with age ranging from 40 to 55 years of both sexes were

enrolled in this study and 50 age matched healthy subjects were control group.

Patients were enrolled from Outpatient Department of Endocrinology, Dhaka

Medical College Hospital, Dhaka. Serum amylase and serum lipase levels were

estimated by spectrophotometry. It was concluded that serum amylase and lipase

levels were significantly lower (P<0.001) in patients of type II DM in comparison

to control group. From this study, it was concluded that exocrine derangement of

pancreas may occur in type 2 diabetes mellitus.

A case-control study[13] was conducted at Biochemistry Department, GMERS

Medical College, Valsad, Gujarat, India by Madole MB, Iyer CM et al to evaluate

serum amylase and lipase levels in diabetes mellitus patients in 2015-2016. Fasting

venous blood samples were collected from the cases as well as the controls and

they were analysed by using semi auto analyser for blood glucose, serum amylase

and serum lipase.The study clearly demonstrated that in diabetes mellitus, there

was increase in fasting blood sugar with decrease in serum amylase and serum

lipase which signifies the derangement of endocrine-exocrine axis of the pancreas.

Serum amylase and serum lipase can be used as biochemical markers for

assessment of pancreatic exocrine function. It was found that fasting blood sugar

was significantly higher in cases as compared to controls. A negative correlation of

fasting blood sugar level with serum amylase and serum lipase and positive

correlation of serum amylase with serum lipase in diabetic patients was found.

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In a case control study[14] conducted at Bangalore medical college and research

centre, Bangalore, India by Vishwanath HL, Shwetha N, 30 age and sex matched

diagnosed cases of type 2 DM between 40-80yr were included in the study and 30

healthy individuals as controls. Study was to assess biochemical analysis of serum

amylase and serum lipase levels in patients of type II diabetes mellitus. It was

concluded that here was a considerable decline in serum amylase (p<0.0001) and

serum lipase (p=0.00661) in diabetic patients compared to controls who were age

and sex matched. It showed pancreatic exocrine destruction in type 2 DM. Serum

pancreatic enzymes can be used as an extra explanatory parameter for the

evaluation of progression of the disease and response to treatment.

In another study[15] conducted by Aughsteen AA et al in Al-Isra Medical

Laboratory, Amman, Jordan during the period from April - November 2003 on

analysis of pancreatic amylase and lipase levels in patients of type 1 and 2 diabetes

mellitus, it was concluded that serum amylase was reduced in both type I and II

diabetes whereas serum lipase was reduced only in type I diabetes. Also, reduction

in levels of both enzymes was higher in long standing illness indicating duration of

disease has a role in affecting the exocrine functioning of pancreas.

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In this large cross sectional study of type 2 diabetic patients from LEADER[16]

(Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome

Results), New England Journal Of Medicine (NEJM) conducted by Steinberg WM,

Nauck MA et al which is a double blinded placebo controlled trial between 2010-

2012 to study activity of serum amylase and serum lipase in type 2 diabetics, it was

concluded that nearly 25% had elevated lipase or amylase levels.

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METHODOLOGY

Study Design: Case control study.

Study Site: Department of General Medicine, SBKS M.I.R.C, Dhiraj Hospital, Sumandeep

Vidyapeeth, Pipariya, Waghodiya, Vadodara.

Sample Size: A sample size of 90 (45 cases and 45 controls), calculated as below

Sample size for case control study [17]

nA=κnB and nB=(1+1κ)(σz1−α/2+z1−βμA−μB)2nA=κnB and nB=(1+1κ)(σz1−α/

2+z1−βμA−μB)2

1−β=Φ(z−z1−α/2)+Φ(−z−z1−α/2),z=μA−μBσ1nA+1nB−−−−−−−√1−β=Φ(z−z1−

α/2)+Φ(−z−z1−α/2),z=μA−μBσ1nA+1nB

where

• κ=nA/nBκ=nA/nB is the matching ratio

• σσ is standard deviation

• ΦΦ is the standard Normal distribution function

• Φ−1Φ−1 is the standard Normal quantile function

• αα is Type I error

• ββ is Type II error, meaning 1−β1−β is power

Duration of enrollment: One and Half Year

The study will be started after clearance from institutional Ethics committee. The study

participants will be enrolled after informed written consent and will be classified into two main

groups. (cases and controls)

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INCLUSION CRITERIA:

• case: 1) age > 18 years.

2) Patients who are known case of type II diabetes mellitus or newly

detected type II diabetes mellitus as per ADA (American Diabetic Association)

criteria will be enrolled as cases.

ADA criteria for diagnosing diabetes mellitus[18]

EXCLUSION CRITERIA:

1) Any person who is not willing to participate in study.

2) Age < 18 years.

3) Patients with acute or chronic pancreatitis.

4) Chronic alcoholic individuals.

5) Patients having gall stones.

6) Type I diabetic patients.

Age and sex matched non-diabetic individuals will be taken as controls after obtaining written

informed consent.

1. HbA1C > 6.5%

2. Fasting plasma glucose >7.0 mol/L (126 mg/dl) [a]

OR

3. Symptoms of Diabetes +

Random blood glucose concentration > 11.1mmol/L (200 mg/dl) [b] OR

4. Two- hour plasma glucose > 11.1 mmol/L (200 mg/dl) during oral

glucose tolerance test. [c]

a: Fasting is defined as no caloric intake for atleast 8 hours

b: random means without regarding to time since the last meal

c: The test should be performed using a glucose load containing the

equivalent of 75 gm anhydrous glucose dissolved in water.

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All participants included in this study will be subjected to complete history including

demographic profile, detailed history about diabetes mellitus and other co-morbidities. Complete

clinical examination including general, systemic and fundus examination will be done.

Serum Amylase and Serum Lipase will be measured in EM200 machine. The levels will be

measured by Enzymatic Colorimetric estimation method in the central lab at Dhiraj Hospital. For

estimation of levels, 2 ml blood will be withdrawn from patient preferably in a fasting state.

Blood will be collected in a plain vacuette with the help of a sterile disposable plastic syringe.

Reference value of S. Amylase – upto 96 U/L

Reference value of S. Lipase – upto 60 U/L

Apart from this, participants will be subjected to routine investigations like complete hemogram

(CBC), urine routine micro, renal function tests, serum electrolytes, liver function tests,

electrocardiography, USG abdomen-pelvis and fasting blood sugar, post-prandial blood sugar

and HbA1c as a part of diabetic work up.

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DATA ANALYSIS

All data will be recorded in CRF (Case Record Form) and compiled in MS office excel. Then

data analysis will be done by statistical software. Descriptive statistics, Odds ratio, Chi Square

test and Regression analysis will be applied for analysis.

Likely outcome and benefit of the study

1) This study will be helpful in generating more data on prevalence of exocrine pancreatic

dysfunction in type II diabetic patients by demonstrating variation in Serum Amylase and

Serum Lipase levels compared to that in non-diabetic individuals.

2) Serum Amylase and Serum Lipase level might show variations in type II diabetes patients

indicating endocrine derangement can involve exocrine part of pancreas.

3) This study will be able to demonstrate effect of duration of type II DM on exocrine

function of pancreas.

4) This study will be helpful to study association between Amylase and Lipase levels with

glycemic control (HbA1c).

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ETHICAL ISSUES

1. At no point of time the patient will be enrolled in the study without his/her consent or

willingness to enroll him/her in above study.

2. This study does not include any treatment experimentation.

3. Study also does not necessitate any harmful procedures. So, this study is not likely to

raise any ethical issues.

4. Most routine investigations required for the study are a part of routine workup of

patients and do not pose heavy financial burden to the patient.

5. As serum amylase and lipase are not a part of routine investigation for type II diabetes

mellitus, I will explain patients the importance and usefulness of the tests as they are the

predictors of damage that can occur to pancreas and cause digestive derangements in

patients by involvement of exocrine pancreas. If the patient agrees, he/she will

contribute in the study or else the primary investigator will bear the cost.

FEASIBILITY ISSUES

Our hospital is rural based tertiary care center. We get many patients of type II diabetes mellitus.

We also have fully equipped 24 hours Central laboratory facility. So all investigations needed for

this study including Serum Amylase and Lipase will be done in the central lab of the hospital

only. So this study is highly feasible at our institute and there are no feasibility concerns.

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“EVALUATION OF SERUM AMYLASE AND SERUM LIPASE AS BIOCHEMICAL

MARKERS OF PANCREATIC EXOCRINE FUNCTION IN TYPE II DIABETES

MELLITUS”

PROFORMA

Initials Age/Sex Weight: Height: BMI:

Address:

OPD No.: IPD No.:

Socioeconomic status (according to Kuppuswamy classification):

Complaints:

Detailed history of diabetes mellitus and history of presenting illness:

Duration: Compliance:

Drug history: others:

Past history

Diabetes: Hypertension:

Coronary artery disease (CAD): Cerebrovascular accident (CVA):

others:

Family history

Personal history

Addiction:

Others:

Menstrual history

General examination

Consciousness: temperature: pulse:

Blood pressure: respiratory rate: lymphadenopathy:

Pallor: icterus: clubbing:

Cyanosis: edema: others:

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Fundus examination

Systemic examination

1) Cardiovascular system:

2) Respiratory system

3) Central nervous system

ankle jerk: plantars:

sensory examination: others:

4) Per abdomen system

Laboratory investigations

Hb: TC: DC: platelets: ESR:

Urine routine/micro: RFT

S. urea: S. creatinine:

LFT

S. bilirubin: SGPT: SGOT:

Serum Electrolytes

S. sodium: S. potassium: S. chloride:

Lipid profile

Cholesterol: Triglyceride: HDL: LDL:

VLDL: Cho/HDL: LDL/HDL:

FBS: PP2BS: HbA1c:

ECG:

USG abdomen-pelvis:

Serum amylase: Serum lipase:

Final diagnosis:

Treatment given:

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REFERENCES

1) S Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetesestimates

for the year 2000 and projections for 2030. Diabetes Care. 2004;27(3):1047-53.

2) Henderson JR, Daniel PM, Fraser PA. The pancreas as a single organ: theinfluence of the

endocrine upon the exocrine part of the gland. Gut. 1981;22:15867.

3) Singh J, Yago MD, Adeghate E. The role of insulin, glucagon,

somatostatin,cholecystokinin, acetylcholine and nerve stimulation in the interactions

between the endocrine and exocrine pancreas in normal and diabetic conditions in rats.

Int J Diabetes. 1999;7(1):114-19.

4) Adler G, Kern HF. Regulation of exocrine pancreatic secretory process by insulin in vivo.

HormMetab Res. 1975;7:290-96.

5) Barreto SG, Carati CJ, Toouli J, Saccone GT. The islet-acinar axis of the pancreas: more

than just insulin. Am J PhysiolGastrointest Liver Physiol. 2010;299:G10-22.

6) Muniraj T, Dang S, Pitchumoni CS. Pancreatitis or not?--Elevated lipase and amylase in

ICU patients. J Crit Care. 2015;30(6):1370-75.

7) Kei N, Tohru N, Toshitaka M, Masafumi K, Hiroshi F, Hiromi M. Low serum amylase in

association with metabolic syndrome and diabetes: A communitybased study.

Cardiovascular Diabetology. 2011;10:34.

8) Aughsteen AA, Abu-Umair MS, Mahmoud SA. Biochemical analysis of serumpancreatic

amylase and lipase enzymes in patients with type 1 and type 2 diabetes mellitus. Saudi

Med J. 2005;26:73-77.

9) Elayat AA; el-Naggar MM; Tahir M; Bassam dahrouj (1995). "An immunocytochemical

and morphometric study of the rat pancreatic islets". Journal of Anatomy. 186. (Pt 3) (Pt

3): 629–37.

10) Chakraborty PP, Chowdhury S (2015) A Look Inside the Pancreas: The “Endocrine-

Exocrine Cross-talk”. Endocrinol MetabSynd 4: 160.

11) Maarten R. Struyvenberg, Camilia R. Martin, Steven D. Freedman. Practical guide to

pancreatic exocrine insuffiency – breaking the myths. BMC Med. 2017; 15:29.

12) Noor-E-Jannat Tanvi, Qazi Shamima Akhter, Sharmin Nahar, Mahmuda Nasrin Sumi,

Mobarak Hosen. Serum amylase and lipase levels in type 2 diabetes mellitus. J

Bangladesh Soc Physiol. 2017, December; 12(2): 52-56.

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13) MaheSh M, ChandraShekhar I, MaMatha M, SatISh W, deepak H. Evaluation of

Biochemical Markers Serum Amylase and Serum Lipase for the Assessment of

Pancreatic Exocrine Function in Diabetes Mellitus. Journal of Clinical and Diagnostic

Research. 2016 Nov, Vol-10(11): BC01-BC04.

14) Vishwanath HL, Shwetha N et al. Biochemical analysis of serum amylase and lipase in

patients with type 2 diabetes mellitus. International Journal of Clinical Biochemistry and

Research, January - March, 2019;6(1):121-125.

15) Aughsteen AA, Abu-Umair MS et al. Biochemical analysis of serum pancreatic amylase

and lipase enzymes in patients with type 1 and type 2 diabetes mellitus. Saudi Med J.

2005 Jan;26(1):73-7.

16) Steinberg WM, Nauck MA. Lipase and Amylase Activity In Subjects With Type 2

Diabetes. Pancreas • Volume 43, Number 8, November 2014.

17) Chow S, Shao J, Wang H. 2008. Sample Size Calculations in Clinical Research. 2nd Ed.

Chapman & Hall/CRC Biostatistics Series. page 58.

18) American Diabetes Association. Diagnosis and classification of diabetes mellitus.

Diabetes Care. 2010;33(Suppl 1):S62–69.

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Participant Information Sheet

TITLE OF STUDY:

“EVALUATION OF SERUM AMYLASE AND SERUM LIPASE

AS BIOCHEMICAL MARKERS OF PANCREATIC EXOCRINE

FUNCTION IN TYPE II DIABETES MELLITUS.”

Case No.____________________ Date:__________________________

Invitation to the Patient

1. Purpose and nature of the study: To study serum Amylase and Lipase levels in diabetes

patients and non-diabetic individuals and its possible co-relation with pancreatic functions.

2. Voluntary nature of participation: The participation in the study program is absolutely on

voluntary basis.

3. Study method: A patient satisfying the inclusion criteria will be evaluated clinically by

detailed history. Routine and special investigations will be studied. The data collected will be

analyzed under various parameters.

4. Participant’s responsibilities: After agreeing to participate in the study, the participant is

expected to extend his full support. He/she should provide real facts when asked into and should

allow the investigator to carry out relevant examination in detail.

5. Expected adverse events, risks and solutions: No adverse events or risks as such exist to the

participant. The study does not include any human or animal experimentation.

6. The benefit of the participation: The study is beneficial to the participant as it will give them

their illness status and help in optimal management. The study is also likely to benefit the

25

community by helping in early recognition of pancreatic dysfunction in diabetics and by

highlighting the association between them.

7. Confidentiality of the report: All the data collected will be kept confidential. Participants

would be given name codes as identity.

8. In case of any problem, contact person:

Dr. Aarsh Shah

Address: Room No. 93, gargi boys hostel

Sumandeep vidyapeeth University Campus,

Piparia, Tal: Waghodia, Dist: Vadodara, 391760.

Contact No. 9925924353

9. Financial consideration: No extra financial burden will be levied on the participant.

10. Protection and security for the patient: If any type of threat or untoward event, consequent

to present study, is met with, the participant will be provided suitable protection. The nature of

threat and protection can be decided when such an event is actually faced with.

11. Obtaining additional information: If need arises, the patient may be contacted to inquire

about additional information.

26

સહભાગી માહહતી પતરક

અભયાસન નામ: "પરકાર II મધમહ માા સવાદપ િડ ના બાહયકારયો ના માકકરક તરીક રીરમ અમારયલર

અન રીરમ લારય ર ના મલરયાાકન"

અભયાસ કરમાાક:__________ તારીખ:______________

આમાતરણ

૧. અભયાસનો પરકાર અન હત:"પરકાર II મધમહ માા સવાદપ િડ ના બાહયકારયો ના માકકરક તરીક રીરમ

અમારયલર અન રીરમ લારય ર ના મલરયાાકન”

૨. સવચછિક સહભાગગતા: અભયાસમાા ભાગ લવો સાપણણપણ મરજિયાત છ.

૩.અભયાસ ની રીત: રમાવશ ના ધોરણો ન રાતોષતા દદી ના પવગતવાર ઇપતહાર દવારા તબીબી

મલરયાાકન કરવા માા આવશ. રીરમ અમારયલર અન રીરમ લારય ર ના અધરયરયન કરવા માા આવશ

અન મધમહ એનડ બબનમધમહ પવષરયો વચ તલના કરવામાા આવશ. પનરયપમત અન પવશષ ત ાર

નો અભરયાર કરવા માા આવશ. એકપિત કરલા ડટા ન પવપવધ રરમાણો હઠળ પવશલષણ કરવા માા

આવશ.

૪. સહભાગીની જવાબદારી: અભયાસમાા ભાગ લવા માટ સહમત થયા પછી સહભાગીએ

તપાસકતાણન તમામ સસાગત તથયો તમિ તપાસમાા સાપણણ સહકાર આપવો પડશ.

૫. અદાજીત આડઅસર, જોખમ અન તનો ઉકલ: આ અભયાસમાા સહભાગી પર કોઈ પરયોગ ક

અખતરા કરવામા આવતા નથી, તથી કોઇ િોખમ ક આડઅસરની સાભાવના નથી.

27

૬. સહભાગગતાનો લાભ: આ અભયાસમાા ભાગ લવાથી સહભાગીન તના રોગવવષ માહહતી મળશ,

જનો લાાબાગાળ તના સારવારમા ફાયદો થશ. આ રોગ વવષ વધાર માહહતી મળવાથી સમાિન

પણ ત લાભદાયી થશ.

૭. માહહતીની ગોપનીયતા: સહભાગીની એકઠી કરલ તમામ માહહતી ગોપનીય રાખવામા આવશ.

૮. કોઇપણ પરકારની તકલીફ માટ સપકક :

ડો.આરક શાહ

રમના. ૯૩, ગાગી છાિાલરય, સમનદી પવદયા ીઠ,

ી ારરરયા, તાલ - વાઘોરડરયા, જિ. વડોદરા, ૩૯૧ ૭૬૦

૯૯૨૫૯૨૪૩૫૩

૯. આરથિક રવકલપ: સહભાગીન રવધરાભાવના રોગન સસાગત તપાસ વસવાય અનય કોઈ તપાસનો

આવથિક બોિ નહહ આપવામા આવ.

૧૦. સહભાગીની સલામરત: ઉપરોકત અભયાસન સસાગત કોઈપણ પરકારના અણબનાવ સામ

સહભાગીન યોગય રકષણ પર પાડવામા આવશ. િરર પડય વધારાની માહહતી માટ સહભાગીનો

સાપકણ કરવામા આવશ.

૧૧. વધ માહહતી પરાપત કરવી: અગર િરર ડી તો વધ મારહતી પછ રછ માટ દદી નો રા કક કરી શકારય છ.

28

परतिभागी सचना पतरक

अधययन का शीरषक: "परकार II मधमह म अगनयाशय क बाहरी कायो क माकक र क

रप म सीरम अमायलस और सीरम लायपस का मलयााकन।"

कस सखया .____________________

दिनाक: __________________________

रोगी को ननमतरण

1.अधययन का उददशय और परकति: "परकार II मधमह म अगनयाशय क बाहरी

कायो क माकक र क रप म सीरम अमायलस और सीरम लायपस का मलयााकन।"

2.भागीदारी की सवचछिक परकति: अधययन कायषकरम म भागीिारी सवचछिक आधार

पर बिलकल ह।

3.अधययन ववधि: समावशन मानिड को सतोरजनक रोगी का ववसतत इनतहास

दवारा निाननक मलयाकन ककया जाएगा; सीरम अमायलस और लायपस का

29

अधययन ककया जाएगा और मधमह और गर मधमह ववरयो क िीच तलना की

जाएगी। एकतर ककए गए आकडो का ववशलरण ववभभनन परामीटर क अतगषत ककया

जाएगा।

4.परतिभागी की चिममदाररयाा: अधययन म भाग लन क भलए सहमत होन क िाि,

परनतभागी को अपन पणष समरषन का ववसतार करन की उममीि ह। पि जान पर

उस वासतववक तथयो को परिान करना चादहए और जाचकताष को परासगगक परीकषा

म ववसतार स जान की अनमनत िनी चादहए।

5.सभाववि परतिकल घटनाओ, जोखिमो और समािानो की उममीद: परनतभागगयो क

भलए कोई परनतकल घटनाए या जोखिम नही ह। इस अधययन म ककसी मानव या

पश परयोग शाभमल नही ह।

6.भागीदारी का लाभ:यह अधययन भागीिार क भलए फायिमि ह कयोकक यह उनकी िीमारी की चसरनत और इषटतम परिधन म मिि करगा। अधययन म मधमह रोगो म अगननाशय रोग की परारमभिक पहचान करक और उनक िीच क सिध को उजागर करक, समिाय को लाभ पहचन की भी सभावना ह।

7.ररपोटट की गोपनीयिा: एकतर सभी डटा गोपनीय रिा जाएगा। परनतभागगयो को

नाम पहचान क रप म दिया जाएगा

8.ककसी भी समसया क मामल, सपकट वयचति:

30

डॉ आशक शाह

जोड: रम निर ९३, गागी िॉयज हॉसटल,

समनिीप ववदयावपठ ववशवववदयालय पररसर,

वपपाररया, तल: वाघोडडया, चजला: वडोिरा, ३९१७६०

सपकष निर ९९२५९२४३५३

9.ववततीय ववचार: भागीिार पर कोई अनतररकत ववततीय िोझ नही लगाया जाएगा।

10.रोगी क ललए सरकषण और सरकषा: अगर ककसी भी परकार का ितरा या अवपरय

घटना, चजसक पररणामसवरप अधययन को परसतत ककया जाता ह, तो इसक सार

मलाकात की जाती ह, परनतभागगयो को उपयकत सरकषण परिान ककया जाएगा। ितर

और सरकषा की परकनत का ननणषय ति ककया जा सकता ह जि इस तरह की घटना

को वासतव म सामना करना पडता ह।

11. अतिररति जानकारी परापि करना: यदि जररत पडती ह, तो अनतररकत

जानकारी क िार म पिताि क भलए मरीज को सपकष ककया जा सकता ह।

31

INFORMED CONSENT FORM

Informed Consent Form (ICF) for Participants in Research Programmes involving studies

on human beings.

STUDY TITLE: “EVALUATION OF SERUM AMYLASE AND

SERUM LIPASE AS BIOCHEMICAL MARKERS OF

PANCREATIC EXOCRINE FUNCTION IN TYPE II DIABETES

MELLITUS”

STUDY NO.:_______________________________ DATE:_____________

Participant’s Initials: ___________

Participant’s Name:_________________________

Date of Birth:________________ Age: ________Years: _______

32

1. I confirm that I have read and understood the information sheet dated ___________ for the

above study and have had the opportunity to ask questions. [ ]

2. I understand that my participation in the study is voluntary and that I am free to withdraw at

any time, without giving any reason, without my medical care or legal rights being affected.

[ ]

3. I understand that the investigator of this study, others working on the investigators behalf, the

Ethics committee and the regulatory authorities will not need my permission to look at my health

records, both in respect of the current study and further research that may be conducted in

relation to it, even if I withdraw from the study. I agree to this access. However, I understand that

my identity will not be revealed in any information related to the third party or get published.

[ ]

4. I agree not to restrict the use of any data or results that arise from this study provided such a

use is only for scientific purpose(s). [ ]

5. I agree to take part in the above study. [ ]

33

Signature/Thumb impression of the participant ____________________________

Legally acceptable representative________________________________________

Signatory’s Name _______________________________Date _________________

Signature of the investigator _____________________ Date __________________

Study Investigator’s Name _______________________ Date _________________

Signature of the impartial witness __________________Date _________________

Name of the witness______________________________________________

34

અભયાસમા ભાગ લવા માટ સમજી રવચારીન આપલી પરવાનગીન સમમરત-પતરક

અભયાસન નામ: "પરકાર II મધમહ માા સવાદપ િડ ના બાહય કારયો ના માકકરક તરીક રીરમ અમારયલર

અન રીરમ લારય ર ના મલરયાાકન"

અભયાસ કરમાાક:___________ તારીખ:______________

સહભાગીન પરા નામ:_____________________________________________________

સહભાગીન ટાક નામ:_____________________________________________________

સહભાગીની િનમતારીખ / ઉમર: ___________________________________________

35

૧. હ ા ખાતરી આપા છા ક મ ઉપરોકત અભયાસની તા: / /) માહહતી વાાચી છ અન સમજી છ અન

ત અગના માઝવતા પરશરનો પછવાની મન તક આપવામા આવી છ.

[ ]

૨. હ ા જાણા છા ક આ અભયાસમાા ભાગ લવો મારા માટ મરજીયાત છ અન, કોઇ પણ જાતન કારણ

આપય વગર, તમાથી ગમ તયાર ખસી િવાની મન છટ છ, અન આમ કરવાથી મારી તબીબી

સારવાર ક કાયદસરના હકકોન કોઇ અસર નહી થાય.

[ ]

૩. હ ા જાણ છા ક આ અભયાસના તપાસકતાણ, તમના મદદનીશો, એવથકલ ટીમ અન તના ઉપર

દખરખ રાખતા અવધકારીઓન મારા સવાસથયની કોઈપણ જાતની માહહતી, સદર અભયાસન લગતી

ક ત વસવાયની, મળવવા માટ મારી પરવાનગીની િરર રહશ નહી, ભલપછી હ ા અભયાસમાાથી

ખસી જાઉ. હ ા જાણા છા ક મારી આ પરકારની માહહતી અનય કોઇન જાણ ક પરવસધધ નહી કરવામાા

આવ. [ ]

૪. આ અભયાસ દરમયાન, અથવા તના અત પરાપત થતી માહહતી, કોઈપણ જાતની વજઞાવનક શોધ

માટ ઉપયોગ કરવા માટ હ ા સવચછછક રીત છટ આપા છા.

[ ]

૫. હ ા આ અભયાસમાા ભાગ લવા / િોડાવા માટ સહમવત આપા છા.

[ ]

અભયાસમાા ભાગ લનારની સહહ અથવા અગઠાન વનશાન:_____________તારીખ:__________

36

કાયદસરના સસવકત તપાસકતાણની સહી: _________________________તારીખ:__________

તપાસકતાણન નામ: _______________________________________________________

તટસથ સાહદ / ગવાહની સહી: ________________________________તારીખ:__________

તટસથ સાહદ / ગવાહન નામ: _______________________________________________

37

सचित सहमतत पतर

इासानो पर अधययन स जड अनसाधान कायककरमो म परतििागगयो क ललए सगचि

सहमति पतर

अधययन शीरकक: "परकार II मधमह म अगनयाशय क बाहरी कायो क माकक र क रपम सीरम अमायलस और सीरम लायपस का मलयााकन।"

अधययनसा.:__________________ दिनााक _____________

परतििागी क परारालिक: ___________

परतििागी का नाम: ________________________

जम तिगि: ________________ आय: ________ वरक: _________

38

1. म पमटि करिा हा कक मन उपरोकि अधययन क ललए ___________ की

जानकारी पतर पढ ललया ह और समझ ललया ह और परशन पछन का अवसर लमला

ह। [ ]

2. म समझिा हा कक अधययन म मरी िागीिारी सवमछछक ह और म ककसी िी

समय बबना ककसीिी कारण दिए बबना वापस लन क ललए सविातर हा, मरी

गचककतसा िखिाल या काननी अगधकारो क बबना परिाववि हो रहा ह [ ]

3. म समझिा हा कक इस अधययन क अवरक, अवरको की ओर स काम

करनवाल अय लोग, एगिकस कमिी और तनयामक परागधकरणो को मौजिा

अधययन और आग क शोध क साबाध म अपन सवासय अलिलखो की मरी

अनमति की आवशयकिा नहीा होगी। म इस पहाच स सहमि हा हालााकक, म

समझिा हा कक मरी पहचान ििीय पकष स साबागधि ककसी िी जानकारी म परकिन

हीा होगी या परकालशि हो जाएगी। [ ]

4. म इस अधययन स उतपन होन वाल ककसी िी डिा या पररणामो क उपयोग

को परतिबागधि करन क ललए सहमि हा, लककन ऐस परयोग कवल वजञातनक उदिशय

(परयोजनो) क ललए ह। [ ]

5. म उपरोकि अधययन म िाग लन क ललए सहमि हा। [ ]

परतििागी क हसिाकषर/अागठ का इापरशन:_____________________________

39

काननी रप स सवीकायक

परतितनगध:________________________________________

हसिाकषर किाक का नाम :____________________ दिनााक: ______________

अवरक क हसिाकषर :______________________दिनााक: ______________

अधययन अवरक का नाम :____________________दिनााक: ____________

तनटपकष गवाह क हसिाकषर :__________________दिनााक: ______________

साकषी का नाम:_____________________________________

40

This dissertation synopsis has been prepared by Dr. Aarsh Rajesh Shah under guidance of Dr.

Hetal Pandya and is being submitted to Departmental and ethics committee for favour of review

and approval

Dr. Aarsh Rajesh Shah

1st Year Resident,

Department of General Medicine

Signature of applicant: ______________________________

Recommendation and signature of PG guide:

Dr. Hetal Pandya, M.D._______________________________

Professor and Head

Department of General Medicine.

Recommendation and signature of Head of the Department:

Dr. Hetal Pandya, M.D.______________________________

Professor and Head

Department of General Medicine