Materials and Methodology Sample
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Materials and Methods Medicine Sample Work
Published 14, July 2011Subjects
The diabetic patients who are attending the MIMS at Calicut during the period of study will included in this study. The study had following inclusion and exclusion criteria.
Inclusion Criteria:
All patients diagnosed to have Type 2 diabetes with less than 5 years of duration
Age between 30-70 years
Both male and female
Exclusion Criteria:
Existing heart diseases
Established liver diseases (SGOT, SGPT ↑3 times; USG features)
Established kidney diseases (Serum Creatinie 1.5 mg/dl, Male and 1.4 mg/dl Female)
H/O treatment with lipid lowering drugs
IP Patient
Medical history: Hypothyrodisim, Alcoholism
Pregnancy
Study Design
The patients were screened between November 2011 to November 2012 (1year) and 50 patients consented to participate in the study. However, at the end of the study period only 40 patients completed the study while remaining 10 patients were dropped out due to several personal reasons such as migration (n=6), diet (n=2) and not interested (n=2). Subjects were randomly assigned using computer generated randomization software to receive appropriate dosage of statins. The following shows the division of groups:
- Group 1: Patients receiving Statin therapy (n=20)
- Group 2: Patients not receiving Stating but followed through diet [(n=20)
Sample size
The available studies on change in pattern of dyslipdemia using statins or dietary effect revealed that a minimum sample size of 20-35 patients is required in each group to compare the two groups with 95% confidence and 80% power. Hence, in the present study, a minimum of 20 patients was included in each Group.
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Read MoreLaboratory Evaluation
Further HbA1c levels, Total Cholesterol, Triglycereide, High Density Lipoprotein level, Very Low density lipoprotein level were measured before and after statin therapy.
Anthropometric measurements
Height, weight and calculated body mass index (BMI) standard
Adverse Events
Safety was assessed by recording all self-reported adverse events (AEs) and serious AEs (SAEs); regular monitoring of hematology, blood-chemical, and urinary values; regular measurement of vital signs; and physical examinations. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Statistical analysis
The Mean and the Standard Deviation of the two variables and the corresponding change in each of the variables after 3 months of treatment in each group shall be computed.
References
Adams, L. A. and Lindor, K. D. (2004) ‘Treatment of hyperlipidemia in nonalcoholic fatty liver disease: Fat for thought’, Indian J Gastroenterol, 23, pp. 127–8.
Ades, P. A., Savage, P. D., Toth, M. J., Schneider, D. J., Audelin, M. C., Bunn, J. Y., et al. (2008) ' The influence of obesity and consequent insulin resistance on coronary risk factors in medically treated patients with coronary disease', Int J Obes (Lond), 32(6), pp. 967-974.
Albert, C. M., Hennekens, C. H., O'Donnell, C. J, et al. (1998) ‘Fish consumption and risk of sudden cardiac death’, JAMA, 279, pp. 23–8.
American Diabetes Association (2004) ‘Diagnosis and classification of diabetes mellitus’, Diabetes Care, 27(l), pp. S1-S2, S5-S10, S15-S35.
American Diabetes Association (2009) ‘Standards of medical care in diabetes-2009’, Diabetes Care, 32(1), p. S13-S61
American Diabetes Association.(2001) ‘Management of dyslipidemia in adults with diabetes (Position Statement)’, Diabetes Care, 24(1), pp. 58–61.
Athyros, V. G., Kakafika, A., Karagiannis, A., Mikhailidis, D. P. (2007) ‘Statins and regression of coronary atherosclerosis’, JAMA, 297, pp. 2197.
Athyros, V. G., Kakafika, A. I., Karagiannis, A., Mikhailidis, D. P. (2008) ‘Do we need to consider inflammatory markers when we treat atherosclerotic disease?’, Atherosclerosis, 200, pp. 1–12.
Athyros, V. G., Kakafika, A. I., Papageorgiou, A. A, et al. (2007) ‘GREACE Study Collaborative Group. Atorvastatin decreases triacylglycerol-associated risk of vascular events in coronary heart disease patients’, Lipids, 42, pp. 999– 1009.
Athyros, V. G., Karagiannis, A., Kakafika, A., Elisaf, M., Mikhailidis, D. P.(2007) ‘Statins and renal function. Is the compound and dose making a difference?’, Nephrol Dial Transplant, 22, pp. 963–4.
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