Materials and Methodology Sample
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Materials and Methods Medicine Sample WorkPublished 14, July 2011
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.
All patients diagnosed to have Type 2 diabetes with less than 5 years of duration
Age between 30-70 years
Both male and female
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
Medical history: Hypothyrodisim, Alcoholism
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)
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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Further HbA1c levels, Total Cholesterol, Triglycereide, High Density Lipoprotein level, Very Low density lipoprotein level were measured before and after statin therapy.
Height, weight and calculated body mass index (BMI) standard
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).
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.
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