Assessment of lipid profile patterns of diabetic patients at Kamuzu Central Hospital
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Date
2021-03-04
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Kamuzu University of Health Sciences
Abstract
Study type: This is a descriptive cross-sectional study assessing lipid profile patterns of
diabetic patients at Kamuzu Central Hospital.
The problem: The burden of diabetes continues to increase globally and in Malawi with a
prevalence of 9.3 and 5.6% respectively. Diabetes is a known high risk factor for
Atherosclerotic cardiovascular disease ASCVD. The elevated risk of ASCVD in diabetic
patients is a product of lipid abnormalities (dyslipidaemias) typical in people with diabetes.
Insulin resistance in diabetes has been shown to contribute to the pathophysiology of
dyslipidaemia in diabetes.
Dyslipidaemia is a modifiable risk factor for ASCVD and can be managed by lowering the
lipid blood levels through low lipid diet, exercises and statin therapy, thereby reducing the
risk for developing adverse complications such as stroke in diabetics. The screening and
monitoring of dyslipidaemia is recommended for people with diabetes to assess the risk and
manage the condition effectively. Assessment of lipid profile patterns and its relationship to
other risk factors to ASCVD can help suggest individual specific management of diabetic
dyslipidaemia. The individualised patient management approach ensures success in patient
lipid control. This would in turn reduce the ASCV-related morbidity and mortality in
diabetic patients. Despite the recommendations, Malawi is still lagging behind in lipid
profile screening and monitoring for diabetic patients. This may be due to various health
system challenges that hinder availability and consistent provision of this essential service.
Current clinical practice at Kamuzu Central hospital includes a 10mg/day prescription of
statin to all diabetes patients. This is done without a lipid test, despite the facility having
these tests available. Underutilization of these relevant tests by the diabetic clinic requires
further investigation. Furthermore, due to the limited lipid profile data in Malawi, the study
aims to assess the lipid patterns and related risk factors associated with dyslipidaemia
among patients being treated for diabetes at Kamuzu Central Hospital.
Study objectives: The main aim of the study is to describe the prevalence, biochemical
characteristic and risk factors associated with dyslipidemia in diabetic patients aged 18-72
years attending the diabetic clinic at KCH.
The specific objectives are to
1. Determine lipid profiles of the adult diabetic participants attending the diabetic
clinic.
2. Calculate the prevalence of dyslipidemia in the study participants using HbA1c.
3. Determine blood HbA1c levels of study participants.
4. Determine the relationship between dyslipidemia and other variables such as
age, sex, body mass index and HbA1c.
Methodology: This will be a descriptive cross-sectional quantitative study. The study
population will be diabetic patients aged 18-72years attending the KCH diabetic clinic. The sample size will be 388 participants. The sample size was calculated using the Conchran
formula, based on an expected prevalence of dyslipidaemia of 40% in this patient
population, with a power of 80% and 5% standard error and 5% attrition). A self-developed
data collection tool (attached in Appedix) will be used to collect participant information
including socio-demographic data (age and sex), information on cardiovascular risk factor
such as smoking and alcohol consumption, and medication history will also be collected.
We will perform anthropometric measures and collect vital signs. Weight and height scales
will be used to obtain participants weight (kg) and height (m) readings. These readings will
be documented on the same self-developed data collection too. BMI will be calculated using
the weight and height readings using the formula: weight divide by square root of the height.
Two blood samples will be collected, one in EDTA tube for HBA1c tests and another in red
topped plane tubes for biochemical lipid profile testing. Whole blood will be used to
measure HBA1c using the NycoCard. Serum will be used to measure lipid levels. Results
will be captured in the data tool developed as well.
Data will then be entered in Microsoft Excel sheet. SPSS and Stata will be used for data
analysis. Descriptive statistics will be presented in a table to describe the general
characteristics of the participants. Chi square test and Fischers test will be used analyse
categorical and independent variables respectively. Stratification of data will be applied to
handle confounders such as smoking and age. The t-test will be used to test the differences
between two means. Correlations between the variables will be tested using Pearson‟s
Product or Spearman‟s test of correlation depending on data normality. In all cases, a pvalue
≤0.05 will be considered significant.
Possible Constraints
A possible constraint to this study could be Covid-19 pandemic. Due to the special risk this
pandemic has on individuals with diabetes, we assumed patient turnout at the clinics would
decline. However, at KCH, the patient turnout at the clinic has not been significantly
affected. So, we envisage that enrolling patients in the study will not be affected. During the
study activities, we will ensure that all Covd-19 preventive measures are strictly adhered to
throughout the course of the study. Clinic staff will monitor and ensure social distancing,
wearing of masks as well as hand washing for clinic staff and patients. Nurses will hand
sanitize before and after attending to each patient to ensure a Covid-19 safety for our clinic
patients.
Expected Findings and Dissemination: The results will aid in providing information on
whether maintenance of the 10mg/day statin therapy for all diabetics being practiced at
KCH is justifiable and adequate or there should be adjusted based on individual patient lipid
results and additional risk factors. The results once analysed will subsequently be published
in an international scientific journal and copies will be presented to the following: The
College of Medicine Research and Ethics Committee (COMREC), College of Medicine
Library, The Health Sciences Research Committee (through the COMREC Secretariat),
The University Research and Publication Committee (URPC) (through the COMREC
Secretariat). Results will also be presented to KCH during monthly ground rounds. A copy
will also be shared with the Malawi Ministry of Health NCD commission.
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Research Subject Categories::MEDICINE