Nepalese Army Institute of Health Sciences (NAIHS)

Sanobharyang, Bhandarkhal, Kathmandu

Research Proposal Form – 2078(2021)

Date:2078/7/15

Proposed Title of the Research:

To study prevalence of metabolic syndrome in COPD patients and its correlation with severity of
COPD

Name of Principal Investigator / Investigator (s):-

No Name In full Highest Degree Department Role in

Research
1 Dr Abinash Karki MBBS Internal Medicine Principle
investigator

Name of Guide (s)/ supervisor (s) :

No Name In full Highest Degree Department Role in

Research
1 Prof Dr Brajendra Srivastava Internal Medicine Guide
MD (TB and
Respiratory Medicine

Background information / introduction;

Place (s) for Research: Shree Birendra Teaching Hospital

Affiliation: Tribhuwan University

Funding Source: Self

Technical Staff (s) involved: No

Introduction

Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines chronic obstructive
pulmonary disease (COPD) as “a common, preventable and treatable disease that is characterized
by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar
abnormalities usually caused by significant exposure to noxious particles or gases.”.(1)

Metabolic syndrome is a common metabolic disorder defined as a complex of interrelated

cardiovascular risk factors. Metabolic syndrome is age dependent and has been related to several
other health conditions and an increased mortality risk.

Insulin resistance is defined clinically as the inability of a known quantity of exogenous or

endogenous insulin to increase glucose uptake and utilization in an individual as much as it does
in a normal population.(2)

The prevalence of Metabolic syndrome in COPD patients is 35.71%.(3 ) Approximately 40–50% of

individuals >60 years of age in industrialized countries meet the criteria for metabolic syndrome. The
metabolic syndrome represents a cluster of risk factors (abdominal obesity, dyslipidemia, hypertension
and insulin resistance) that predispose affected patients
to systemic inflammation, cardiovascular disease and physical inactivity.

Aims and Objectives

To study prevalence of metabolic syndrome in COPD patients and its correlation with severity of
COPD

Specific Objectives

1. To find the prevalence of the metabolic syndrome in the COPD patients

2. to find the correlation of metabolic syndrome with the COPD severity
3. Prevalence of metabolic syndrome and its components in male and female COPD by BMI ≤ 25
mg/m2
4. Prevalence of metabolic syndrome and its components in male and female COPD by BMI .≥25
kg/m2.

Research Design and Methodology

 Research Method- Quantitative

 Types of study- Hospital based Observational, Cross-sectional study

 Study population/ Sampling frame:

Sample size will be calculated using the formula

n=Z2P(1−P) e2 Where n is the sample size,
Z is the statistic corresponding to level of confidence,
P is expected prevalence (that can be obtained from same studies or a pilot study
conducted by the researchers), =35.71 and
e is margin of error=8%
Sample size= 138 COPD patients taken for study.
 Study Site

The study will be conducted in the Department of Internal Medicine, Shree Birendra
Hospital.

 Study population/ Sampling frame

Patients admitted in the ward and coming to OPD under the department of Internal
Medicine will be included in the study.
 Sampling method- non probability sampling
 Expected duration of study: -2079/1/1- 2079/12/30

Inclusion Criteria

Patients will be included in this study if they met the following criteria:

1. Primary diagnosis with COPD.

2. Willing to give consent and take part in the study

For patients with multiple hospital admissions, only the last admission will be included in the
study

Exclusion Criteria

1. Active pulmonary tuberculosis

2. Patients with Asthma
3. Patients with ischemic heart disease, and renal failure
4. Patients with any kind of malignancy diagnosed in last 5 years

Material and Method

Patients presenting with COPD to the medical OPD and or admitted to the ward will be
selected. Screening will be done as per inclusion and exclusion criteria. With informed
consent relevant data will be recorded in predesigned proforma. History taking and relevant
examination will be done.
 Anthropometric measurement will be taken according the required variables

Blood pressure will be measured of each individual using a standard cuff size

Lipid profile, fasting blood glucose will be analyzed by the lab

International Diabetes Federation (IDF) definition of metabolic syndrome:

Waist circumference (WC ≥94 cm in European men or ≥80 cm in European women) Plus two of the
following

1. Fasting glucose ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type II diabetes;
2. triglyceride ≥150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality; N
3. high density lipoprotein (HDL) ≤40 mg/dL (1.03 mmol/L) in men or ≤50 mg/dL (1.29 mmol/L)
in women or specific treatment for this lipid abnormality;
4. systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or treatment of
previously diagnosed hypertension

COPD severity criteria will be defined as the GOLD guidelines as follows

GOLD 1 Mild FEV1≥80%of

predicted
GOLD 2 Moderate FEV1≥50%and <80%
predicted
GOLD 3 Severe FEV1≥30% and
<50% predicted
GOLD 4 Very Severe FEV1<30% predicted

Expected outcome of the Research

There is a correlation between the components of the metabolic syndrome and severity of the
COPD
Statistical Method to be employed
1. Data will be collected and analyzed by SPSS version 21.
2. Categorical variables are described as frequencies
3. Continuous variables will be checked for normality and described as mean, SD or
median.
4. Evaluation of group differences (patients with vs. without metabolic syndrome) in
means for continuous variables was done using the Unpaired Student’s t-test, and for
categorical variables the chi-square test. A p-value of #0.05 will be considered
significant.
  Limitation of the study
The study is conducted at Shree Birendera hospital a tertiary care center so the sample taken
may not be representative for general population as patients included in the study will be
from the Army Background only.

RESULTS
Prevalence of metabolic syndrome in COPD patients
Metabolic syndrome Total
patients no %

Prevalence of metabolic syndrome in different severity of COPD patients

severity Metabolic syndrome non- metabolic total
syndrome
mild
moderate
severe
very severe

Prevalence of Metabolic Syndrome components in COPD patients

Metabolic Syndrome Components Prevalence
Hypertension
Impaired fasting glucose
Abdominal obesity
Elevated triglycerides
Low HDL cholesterol
Demographic, functional parameters of syndrome of COPD patients
ITEMS PATIENT MEAN+SD TOTAL
Age
Sex
Waist circumference
Fasting blood sugar
Blood Pressure
Triglycerides
HDL
Conceptual Framework

Flow Diagram

Patients with COPD No

visiting Shree Criteria for inclusion fulfilled
Excluded
Birendra Hospital,
Chhauni
Yes No
Excluded
Consent
Yes

Proforma

Include samples till the

predetermined sample size is
reached

Data tabulation,
analysis and results
interpretation

Work Plan
 GANTT CHART
Particulars Date

Year 2022 2023

2021

Month Dec Jan Feb Mar Apr May Jun Jul Aug Sep Nov Dec Jan

Literature Review
Topic Selection
Proposal Writing
Submission to
IRB
Data collection
&entry
Data analysis
Thesis writing
Submission for
approval
This is a proposed timeline for the study and may vary slightly per requirement of the study

Ethical Consideration

1. Regarding the Human Participants

Human participants are involved in this study. No harm will be done to participants
involved in the study. The form will be filled by us. They will not be forced to take part
in this study.
2. Obtaining the Consent
Written consent will be taken from individual patients prior to sample collection.
3. Budget
Budget Justification: Printing of informed consent and pro-forma sheet and lab
investigations are the primary expenditures of the study. The patients will not have to
bear any cost for the study.
Estimated budget: Rupees Fifty Thousand only (Rs 50000)
Funding will be done by the researcher.

References
1. Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, et al. Global strategy for the
diagnosis, management, and prevention of chronic obstructive lung disease: the GOLD science
committee report 2019. European Respiratory Journal. 2019;53(5).
2. Lebovitz HE. Insulin resistance: definition and consequences. Exp Clin Endocrinol Diabetes.
2001;109 Suppl 2:S135-48.
3. Singh, N.K., Karki, L., 2021. Metabolic Syndrome in Patients with Chronic Obstructive Pulmonary
Disease in Medicine Department of a Tertiary Care Hospital: A Descriptive Cross-sectional Study.
J. Nepal Med. Assoc. 59. https://doi.org/10.31729/jnma.6410
Patient no- Date

Name-

Age- Sex-

Address-

Contact number-

Occupation-

Presenting Complaints-

Past Histories and Comorbidities- IHD (Yes/No)

CKD (Yes/No)

Malignancy (Yes/No)

 HTN(Yes/No)

Smoking History: Current Smoker ()/ Former Smoker ()/ Never Smoker ()

Pack Smoking Year-

Patient on- Bronchodilator: yes () / No ()

Steroids: Yes ()/ No ()

Domiciliary O2: Yes ()/ No ()

Examinations
Blood pressure- mmhg

Pulse- bpm

Respiratory rate:

<30 ()

30-40 ()

>40 ()

Gasps ()

Anthropometric measurements

a. waist circumference:

b. height:

c. weight:

Pulmonary function test

laboratory test

a. lipid profile

b. fasting blood sugar

PERSONAL PROFILE

Name Dr. Abinash Karki

Date of birth December 20, 1992
Nationality Nepali
Gender Male
Marital status Unmarried
Permanent Address Urlabari4, morang
Dallu,
Contact Address
Kathmandu, Nepal
Contact no 9840776076
Email address abinashkarki689@gmail.com
NMC registration no 22820

ACADEMIC QUALIFICATION

Year of Marks (in%

Degree Board College
passing age)
Northern
Bachelor in International
Dhaka 2074 B.S
Medicine and 75.65% Medical
University (2017 AD)
Bachelor in Surgery College
Bangladesh
Higher Capital Higher
Higher Secondary 2068B.S
Secondary 66.80% sec school,
Education (10+2) (2011 AD)
Education Board Kathmandu
Pasupathi
School Leaving Nepal S.L.C. 2065 B.S
80.88% aawasiya ma vi
Certificate (SLC) Board (2009 AD)
,urlabari
 LETTER OF CONSENT

I Mr. /Mrs.………………………………………………. have been explained fully about the

purpose and procedure of the study titled “To study prevalence of metabolic syndrome in COPD
patients and its correlation with severity of COPD.” by Dr. Abinash Karki that is going to be
held in Shree Birendra Hospital. I am willingly participating in the study. I have been assured
that confidentiality will be maintained to the upmost and no names, documents or results will be
disclosed or circulated anywhere other than the hospital doctors or research guide and co-guide. I
am also aware that I have full rights to withdraw my participation from this study whenever I
wish to do so. My treatment will not be compromised even if I withdraw from the study in
between. I will neither be charged extra costs nor be paid any extra benefits regarding this study.
I am letting to do all examinations in and do all the investigations & procedures as required for
the study. I hereby agree to participate in the study.

Participant’s Signature: Consent taken by:

Full Name:

Finger Print

Left Right

Date:
 सुसचि
ू तमंजुरिनामा

म______________________________ (उमे र_______वर्ष)

ले डा.AbinashKarki ले गर्नलाग्नु भएको“Prevalence of metabolic syndrome in COPD and
its correlation with the severity ” शिर्षककोअनु सन्धानसम्बन्धीसं लग्नमिति२०७ / / को
“जानकारीपत्र/पु स्तिका”
सु नेर/पढे ररप्रश्नोत्तरसमे तगरे रयोअध्ययनअनु सन्धानसम्बन्धमाजानकारीप्राप्तभयो।
योअनु सन्धानकार्यमामे रोसहभागितामे रोव्यक्तिगतइच्छामाभरपर्नेरमै लेचाहे कोखण्डमाकुनै पनिबे ला
योअनु सन्धानप्रक्रियाबाटबाहिरिनपाउने भन्ने कुरामै लेबुझेकोछु।
यसकोलागिमै लेकुनै कारणदिनु नपर्ने रत्यसबाटमै लेपाउने सेवारमे रोकानु नीअधिकारमाअसरनपर्नेसमे त
मलाईबु झाईएकोछ।
यसअनु सन्धानकोप्रतिवे दनवासम्बन्धितप्रकाशितकृतिहरुमामे रोकुनै व्यक्तिगतपरिचयखु ल्ने जानका
रीप्रकाशितहुने छैनभन्ने कुरामै लेबुझेकोछु।यीसबै कुराहरुजानी-बु झी,
मयसअध्ययनअनु सन्धानमासहभागीहुनस्वे च्छाले राजीभईयोसु सचि
ू तमन्जु रीनामामासहिछापगरे को
छु।

अनु सन्धानकर्ताकोसही……………………

सहभागीकोसही: …………
ठे गाना ……………………………...
सहभागीकोनामथर :…………………….

मिति: २०७ / /

बायाँ दाहिने
 Additional information;

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Signature of

……............................ …………………………………….
………………………………
Principal investigator Guides Co – guide
Dr. abinashkarki Prof DrBrajendraSrivastav

……………………………………………….
Head / in charge of Department (s)
Col Dr Ajay Rajbhandari