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The Effect Of Antidiabetic Agent Glibenclamide And Meltformine On Lipids And Glycated Haemoglobin In Type 2 Diabetes Patient Attending Uith Ilorin
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CHAPTER THREE
3.1 Material and Method
3.2 Study Area
The study was carried out at University of Ilorin Teaching Hospital, Ilorin, Kwara State. The hospital is located at the State capital of Ilorin, Kwara State Nigeria. It is a referral center to other public and private hospitals within and outside the state.
3.3 SAMPLE SIZE DETERMINATION
There was a random selection of ninety (90) subjects, 60 were type 2 Diabetes mellitus individual using either one or combine antidiabetic agent (glibenclamide and meltformine) and 30 subjects (control) with normal fasting blood glucose in this retrospective study.
3.4 COLLECTION OF SAMPLE
Full demographic and medical history were collected from all subjects including age, smoking habit, duration of diabetes, type of treatment, and complications. All patients underwent a complete physical examination including measurement of height, weight, waist circumference (WC), and body mass index (BMI, kg/m2) was calculated. From each subject, 10 mL fasting venous blood was collected by vein puncture, using 10ml disposable syringes. The blood sample was divided into two aliquots; 4 and 6 ml respectively. The first aliquot of 4ml blood was dispensed in a tube containing Ethylene Diamine Tetra acetic acid (EDTA) for glycated hemoglobin (HbA1c) estimation, while the second aliquot of 6ml was dispensed in a plain tube and left to clot at room temperature (25 °C). It was then separated by centrifuge at (3000 rpm) for (10min) to collect serum and stored in the deep freezer (-20 0 C) until the assay day.
Subjects with renal failure, cushing syndrome or with ascites due to any reason were excluded. Patients with secondary hypertension, hepatobilliary disease and hypothyroidism were as well excluded from the study after thorough clinical evaluation and patients taking drugs that may affect the results of the study such as hypolipidemic agents were excluded.
3.5 MEASUREMENT OF VARIABLES
Estimation of the concentration of glycated haemoglobin, Total cholesterol, Triglycerdes, HDL-Cholesterol using spectrophometery method and calculation of LDL-cholesterol by ferdwald formula. The parameters measured by enzymatic methods: glucose kit supplied by Spinreact, Spain, Glucose-6-phophatase Enzyme from Cusabio, Chinam, Glycated haemoglobin (GHb) from Infopia, Korea, HDL-Cholesterol, Total Cholesterol and Triglyceride from Randox, U.K.
3.6 STATISTICAL ANALYSIS
The data obtained from the study will be inputted into computer and analyzed using the statistical package for Social Sciences (SPSS). The data will be presented in table, pie chart, histogram and subjected to ANOVA, chi-square test and student T-test. P<0.05 will be considered significant at 95% confidence level.
3.7 ETHICAL CONSIDERATION AND INFORMED CONSENT
Approval for the study will obtained from the Health Research Committee of Kwara State. The participants will be informed on the objectives, benefits and procedure of the study will be explained to them and they will be assured of the confidentiality of the information provided. Each voluntary participant will be identified with unique number. A written informed consent through questionnaire will be obtained from each of the participant before enrolment into the study.
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