Materials and methods medicine sample work

Materials and methods medicine sample work

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Materials and Methods Medicine Sample Work

Published 14, July 2011

Subjects

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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Laboratory 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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