Comparison of Lipid Profile Among Smokers and Non-Smokers

Prepared By: Dr.

Supervisor: Prof. Dr.

Program: FCPS

Institute:
COVER LETTER FOR SYNOPSIS

The Director,

Research and Training Monitoring Cell,

College Of Physicians and Surgeons Pakistan,

7th Central Street, Phase II

DHA, Karachi-75500

Dear Sir/Madam,

Enclosed here is research proposal titled:

“Comparison of Lipid Profile Among Smokers and Non-Smokers ”

Prepared By: Dr.

RTMC Registration No:

CPSP ID:

FCPS - I Roll No:

Trainee Signature: ____________

Name of Supervisor: Prof. Dr.

Name of Training Institute:

Department:

Sincerely,

Supervisor Signature with Stamp: ______________________________

The Director,

Research and Training Monitoring Cell,

College Of Physicians and Surgeons Pakistan,

7th Central Street, Phase II

DHA, Karachi-75500

Subject: Certification of Non-Repetition of Research Topic in Past 5 Years

Respectfully,

It is stated that Dr. __________________________ has a research protocol titled “Comparison

of Lipid Profile Among Smokers and Non-Smokers” This research has not been done in this
institution in the past five years. It may be considered for approval as a mandatory requisite for
FCPS.

Sincerely,

Supervisor: ___________________________________
 Comparison of Lipid Profile Among Smokers and Non-Smokers

Introduction

Globally, consuming tobacco is one of the leading causes of preventable morbidity and
mortality. Tobacco consumption, a leading cause for noncommunicable disease, accounts for
63% mortality at a global level. The low- and middle-income countries are worst affected with
80% mortality rate due to tobacco consumption. According to a report from the World Health
Organization, the projected population of smokers during the year 2020–2030 is estimated to be
1.8 billion, which could increase to 2.2 billion by the year 2050. (1)

The link between dyslipidemia and smoking has received significant focus in medical research
due to the profound impact these factors have on cardiovascular health. Dyslipidemia involves
abnormal levels of lipids in the blood, including changes in low-density lipoprotein cholesterol
(LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, and is a recognized
risk factor for various cardiovascular diseases, including coronary artery disease and stroke. (2)
Substantial evidence has accumulated to suggest that smoking may exert a detrimental influence
on lipid metabolism, leading to exacerbation of dyslipidemic states. Various mechanisms have
been proposed to explain the contributory role of smoking in dyslipidemia, including the
alteration of enzyme activities responsible for lipid metabolism, increased oxidative stress, and
systemic inflammation (3–5)

In the comparative analysis of lipid profiles among non-smokers (N=72) and smokers (N=71),
statistically significant differences were observed across all parameters. Total cholesterol varied
between groups (4.55 ± 0.90 vs 5.23 ± 1.41 mmol/l, P=0.001). Triglycerides also differed (1.72 ±
0.75 vs 2.29 ± 1.12 mmol/l, P=0.001). HDL-cholesterol levels were lower in smokers (1.34 ±
0.37 vs 1.04 ± 0.22 mmol/l, P=<0.001). LDL-cholesterol was elevated in smokers (2.42 ± 1.11
vs 3.14 ± 1.36 mmol/l, P=0.001). VLDL-cholesterol followed the same trend (0.38 ± 0.18 vs
0.45 ± 0.22 mmol/l, P=0.001) (6). Another study on 2,311,709 residents reported that the lower
mean TC levels in current smokers (4.05±0.81) compared to non-smokers (4.21±0.87, t=2.403,
P=0.017). No association was observed between cigarette smoking and risk for abnormal serum
lipid/lipoprotein levels in both unadjusted and adjusted multiple logistic regressions (7). In a
recent study by Babyjohn et al. (2023), 50 smokers and 50 non-smokers aged between 20 to 40
years were evaluated. In smokers, levels of total cholesterol, LDL, VLDL, and triglycerides were
245.58±39.79, 171.04±35.18, 43.74±10.56, and 217.26±42.15, respectively. Conversely, in non-
smokers, these values were 147.64±18.29, 86.16±15.22, 15.30±5.51, and 127.40±10.56,
respectively (p<0.001 for all comparisons). Additionally, HDL levels were significantly lower in
smokers (30.82±3.41) compared to non-smokers (46.16±4.97), with a statistical significance of
p<0.001. (8)

Inconsistent findings regarding the impact of smoking on lipid profiles highlight the need for
more detailed analysis. This research proposal focuses on a comparative study of dyslipidemia
between smokers and non-smokers, specifically examining key lipid parameters: total
cholesterol, LDL, HDL, and triglycerides. By exploring these variations, the study aims to address
and clarify the current discrepancies in existing research. The results could provide vital insights
for clinical practices and inform public health policies by shedding light on how smoking
influences lipid alterations.

Objective

To compare the lipid profiles of smokers and non-smokers by assessing variations in levels of
total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein
cholesterol (HDL-C), and triglycerides.

Operational definitions

Smoker: Individuals who actively smoke tobacco products, categorized by "pack-years," which
is calculated by multiplying the number of packs smoked per day by the number of years the
person has smoked. A pack-year is defined as twenty cigarettes smoked every day for one year.
The study will consider individuals with varying pack-years as smokers, providing stratification
for analysis. For instance, light smokers (1-10 pack-years), moderate smokers (11-20 pack-
years), and heavy smokers (>20 pack-years). Confirmation of smoking status will be through
self-report.
Non-Smokers: Individuals who have never smoked. Confirmation of smoking status will be
through self-report.

Dyslipidemia: Dyslipidemia will be operationally defined as an abnormality in lipid levels based

on the following criteria:

1. Elevated Total Cholesterol: Levels greater than 200 mg/dL.

2. Elevated LDL-Cholesterol (Low-Density Lipoprotein): Levels greater than 100 mg/dL.
3. Reduced HDL-Cholesterol (High-Density Lipoprotein): Levels less than 40 mg/dL for men
and less than 50 mg/dL for women.
4. Elevated Triglycerides: Levels greater than 150 mg/dL.
Blood test for the analysis of lipid profile will be performed after 8 hours of overnight fasting.

Materials and Methods

Study design: Analytic Cross-sectional study.

Study setting: Department of Medicine, ________________________.

Study Duration: 6 months after approval of synopsis.

Sampling technique: Non-probability consecutive sampling technique

Sample size: A sample size of 96 (48 in each group) has been calculated with a 95% confidence
interval and 80% power, based on the assumption that the total serum cholesterol levels differ
between smokers and non-smokers, with values estimated at (4.55 ± 0.90 vs 5.23 ± 1.41
mmol/l). (6).

Sample selection:

Inclusion criteria

● Participants aged between 18 to 60 years

● Active smokers/
 ● Non-smokers with no history of tobacco use

● Willingness to participate and provide written informed consent

● Availability of a recent fasting lipid profile or willingness to undergo such a test for the

study

Exclusion Criteria

● Body Mass Index (BMI) exceeding 30 Kg/m^2.

● Presence of conditions known to affect lipid profiles, such as diabetes, hypertension,

liver impairment, kidney disease, thyroid disorders, or obesity.

● Use of specific medications like beta blockers, lipid-lowering agents, diuretics, and

steroids.

● Engagement in physical activities known to impact lipid profiles.

● Individuals who smoke tobacco infrequently or irregularly, not qualifying as active

smokers based on pack-years.

● Individuals currently on medication for dyslipidemia.

● History of alcohol abuse.

Data collection procedure

After taking approval from ethical review board of hospital, a cross-sectional study will be
conducted in the Department of Medicine at ________________________. Sample will be
collected from the OPD using non-probability consecutive sampling technique. Subjects will be
fully informed about the study objectives and protocols, and written informed consent will be
secured prior to participation. A comprehensive medical and lifestyle history will be acquired
from each subject in order to fulfil selection criteria. Blood samples will be collected following
overnight fasting; specifically, 3 ml of venous blood will be collected using aseptic precautions
and stored in a plain vial. The collected samples will undergo centrifugation at 2000 rpm for one
minute to facilitate serum separation. Lipid profiles will subsequently be assessed on a MIURA
autoanalyzer operating on spectrophotometric/colorimetric principles, measuring parameters
such as serum total cholesterol, high-density lipoprotein, and triglycerides. Finally, low-density
lipoprotein cholesterol levels will be calculated using the equation: LDL (mg/dl) = total
cholesterol (mg/dl) – HDL (mg/dl) – Triglycerides (mg/dl)/5. Data will be collected using data
collection performa.

Data analysis

Data will be analyzed using the Statistical Package for Social Sciences (SPSS, version 25).
Categorical variables, such as smoker status, intensity (light, moderate, heavy) and the presence
of dyslipidemia, will be presented as frequencies and percentages. Continuous variables,
including levels of total cholesterol, LDL-C, HDL-C, and triglycerides, will be summarized as
mean ± standard deviation for normally distributed data. To compare these variables between
groups, chi-square or Fisher's exact test will be utilized for categorical variables depending on
the expected frequencies. For continuous variables, the independent t-test will be used.
Additionally, confounding variables such as age, gender, BMI will be considered, and a stratified
analysis will be conducted. Post-stratification the unpaired t-test will assess their effect on
continuous outcomes and chi-square will be used to compare the effect of these variables on
dyslipidemia among two groups. The significance level for all tests will be set at a p-value of less
than 0.05.
References
1. Kumar A, Narayanaswamy S. Comparative Study of Lipid Profile among Young Smokers
and Nonsmokers in South Indian Population. Med J Dr DY Patil
Vidyapeeth.2023;16(7):132–5.
2. Hedayatnia M, Asadi Z, Zare-Feyzabadi R, Yaghooti-Khorasani M, Ghazizadeh H,
Ghaffarian-Zirak R, et al. Dyslipidemia and cardiovascular disease risk among the
MASHAD study population. Lipids Health Dis.2020;19(1):42.
3. Balhara YPS. Tobacco and metabolic syndrome. Indian J Endocrinol Metab.2012 [cited
2023 Oct 14];16(1):81. Available from: /pmc/articles/PMC3263202/
4. Wang Z, Wang D, Wang Y. Cigarette Smoking and Adipose Tissue: The Emerging Role
in Progression of Atherosclerosis. Mediators Inflamm.2017;2017.
5. Moradinazar M, Pasdar Y, Najafi F, Shahsavari S, Shakiba E, Hamzeh B, et al.
Association between dyslipidemia and blood lipids concentration with smoking habits in
the Kurdish population of Iran. BMC Public Health. 2020 May;20(1):673.
6. Rashan MAA, Dawood OT, Akram H, Razzaq A, Hassali MA. The Impact of Cigarette
Smoking on Lipid Profile among Iraqi Smokers. Int J Collab Res Intern Med Public
Heal.2016;8(8):491–500.
7. Yan-Ling Z, Dong-Qing Z, Chang-Quan H, Bi-Rong D. Cigarette smoking and its
association with serum lipid/lipoprotein among Chinese nonagenarians/centenarians.
Lipids Health Dis.2012;11(1):1. Available from: Lipids in Health and Disease
8. Babyjohn S, John MB, Thomas NM, Joy J, Augustine DJ, Martin KM. The comparative
study of lipid profile in young smokers and non-smokers between 20-40 years. Int J Acad
Med Pharm. 2023;5(3):2094–8.
 Data Collection Performa

Comparison of Lipid Profile Among Smokers and Non-Smokers

Case ID: ______________________ MR number: ______________

Gender: Male / Female Age: ______ years

BMI: _____________

Smoking Status

Do you currently smoke?:

Yes

No

If yes, specify pack-years:

Light smokers (1-10 pack-years): ______

Moderate smokers (11-20 pack-years): ______

Heavy smokers (>20 pack-years): ______

Lipid Profile

Total Cholesterol: ______ mg/dL

LDL-Cholesterol: ______ mg/dL

HDL-Cholesterol: ______ mg/dL

Triglycerides: ______ mg/dL

Dyslipidemia: YES / NO