Research Methodology Materials and Methods

Patterns of Dyslipidemia and effect of Confidential
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Table of Contents
CHAPTER III.............................................................................................................................................. 3
MATERIALS AND METHODS ............................................................................................................ 3
3.1. Study Design and Participants .................................................................................................... 3
3.2. Subjects ...................................................................................................................................... 3
3.2.1. Inclusion Criteria ................................................................................................................. 3
3.2.2. Exclusion Criteria ................................................................................................................ 3
3.3. Study Design .............................................................................................................................. 4
3.3.1. Randomization ..................................................................................................................... 4
3.4. Sample size ................................................................................................................................. 4
3.5. Treatment Protocol ..................................................................................................................... 4
3.6 Anthropometry, blood analysis ................................................................................................... 4
3.6.1. Laboratory Evaluation ......................................................................................................... 4
3.6.2. Anthropometric measurements ............................................................................................ 5
3.7. Adverse Events ........................................................................................................................... 5
3.8. Statistical analysis ...................................................................................................................... 5
References:.............................................................................................................................................. 6
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CHAPTER III
Materials and Methods
3.1 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.
3.1.1. Inclusion Criteria:

1. All patients diagnosed to have Type 2 diabetes with less than 5 years of duration
2. Age between 30-70 years
3. Both male and female
3.1.2. Exclusion Criteria:

1. Existing heart diseases
2. Established liver diseases (SGOT, SGPT 3 times; USG features)
3. Established kidney diseases (Serum Creatinie 1.5 mg/dl, Male and 1.4 mg/dl
Female)
4. H/O treatment with lipid lowering drugs
5. IP Patient
6. Medical history: Hypothyrodisim, Alcoholism
7. Pregnancy
All patients provided written informed consent before participating in the

study, and local Independent Ethics Committees or Institutional Review Boards for
each participating study approved the protocol. The study was conducted in
compliance with the ethical principles of the Indian Council of Medical Research
(2008) and local applicable laws and regulations.
3.2. Study Design
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3.2.1. Randomization
The patients were screened between November 2011 to November 2012
(1year) and 50 patients consented to participate in the study. A random number
generator randomly partitioned the Confidential
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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)
3.4. 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.
3.5. Treatment Protocol

Statins was given for over a period of 12 months
3.6 Anthropometry, blood analysis
3.6.1. Laboratory Evaluation

Further HbA1c levels, Total Cholesterol, Triglycereide, High Density
Lipoprotein level, Very Low density lipoprotein level were measured before and after
statin therapy.
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3.6.2. Anthropometric measurements
Height, weight and calculated body mass index (BMI) standard
3.7. 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).
3.8. 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. Confidential
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differences between group. P value <0.05 was considered significant.
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References
1. Adams, L. A. and Lindor, K. D. (2004) Treatment of hyperlipidemia in
nonalcoholic fatty liver disease: Fat for thought, Indian J Gastroenterol, 23,
pp. 1278.
2. 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.
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3. Albert, C. M., Hennekens, C. H., O'Donnell, C. J, et al. (1998) Fish
consumption and risk of sudden cardiac death, JAMA, 279, pp. 238.
4. American Diabetes Association (2004) Diagnosis and classification of

diabetes mellitus, Diabetes Care, 27(l), pp. S1-S2, S5-S10, S15-S35.
5. American Diabetes Association (2009) Standards of medical care in diabetes-

2009, Diabetes Care, 32(1), p. S13-S61.
6. American Diabetes Association.(2001) Management of dyslipidemia in adults

with diabetes (Position Statement), Diabetes Care, 24(1), pp. 5861.
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7. Athyros, V. G., Kakafika, A., Karagiannis, A., Mikhailidis, D. P. (2007)
Statins and regression of coronary atherosclerosis, JAMA, 297, pp. 2197.
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8. 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. 112.
9. 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.
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10. 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. 9634.
11. Athyros, V. G., Mikhailidis, D. P., Didangelos, T. P. et al. (2006) Effect of

multifactorial treatment on non-alcoholic fatty liver disease in metabolic
syndrome: a randomised study, Curr Med Res Opin, 22, pp. 87383.
12. Athyros, V. G., Mikhailidis, D. P., Kakafika, A. I. et al. (2007) Identifying and
attaining LDL-C goals: mission accomplished? Next target: new therapeutic
options to raise HDL-C levels, Curr Drug Targets, 8, pp. 4838.
13. Athyros, V. G., Mikhailidis, D. P., Liberopoulos, E. N. et al. (2007) Effect of

statin treatment on renal function and serum uric acid levels and their relation
to vascular events in patients with coronary heart disease and metabolic
syndrome: a subgroup analysis of the GREek Atorvastatin and Coronary heart
disease Evaluation (GREACE) Study, Nephrol Dial Transplant, 22, pp. 118
27.
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Materials and Methods

3.1.1. Inclusion Criteria:

3.1.2. Exclusion Criteria:

All patients provided written informed consent before participating in the

3.2. Study Design

Group 1: Patients receiving Statin therapy (n=20)

3.4. Sample size:

3.5. Treatment Protocol

3.6 Anthropometry, blood analysis

3.6.1. Laboratory Evaluation

3.7. Adverse Events

3.8. Statistical analysis:

4. American Diabetes Association (2004) Diagnosis and classification of

5. American Diabetes Association (2009) Standards of medical care in diabetes-

6. American Diabetes Association.(2001) Management of dyslipidemia in adults

9. Athyros, V. G., Kakafika, A. I., Papageorgiou, A. A, et al. (2007) GREACE

11. Athyros, V. G., Mikhailidis, D. P., Didangelos, T. P. et al. (2006) Effect of

13. Athyros, V. G., Mikhailidis, D. P., Liberopoulos, E. N. et al. (2007) Effect of

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