Diabetes patients with dyslipidemia Nutritional, Metabolic, Endocrine Dyslipidemia
Conditions
Interventions
Once the enrolment of the patient is through he will be kept on:
1. Tab. rosuvastatin 10 mg once a day if his LDL level ranges between 100 mg/dL to 130 mg/dL for first 6 weeks, or
2. Tab. rosuvastatin
Sponsors
Ranbaxy Laboratories Ltd (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes type II defined by American Diabetes Association criteria of fasting venous plasma glucose of greater than or equal to 126 mg/dl, two-hour post prandial plasma glucose of greater than or equal to 200 mg/dl or already on treatment of diabetes 2. Dyslipidemia defined by Low Density Lipoprotein (LDL) cholesterol more than 100 mg/dl or on prior statin therapy 3. Age of greater than or equal to 30 and less than or equal to 70 years 4. Informed consent by the patient
Exclusion criteria
Exclusion criteria: 1. Failure to give informed consent 2. A history of hypersensitivity to statins 3. Evidence of fundoscopy grade 2 hypertensive or diabetic retinopathy 4. Serum creatinine greater than 1.5 mg/dl 5. Overt proteinuria 6. Pregnant or lactating mothers 7. Evidence/history of heart failure 8. Systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg 9. Recent history of cerebrovascular disease, myocardial infarction, unstable angina, new onset Left Bundle Branch Block (LBBB) in the past 4 weeks 10. Documented case of homozygous familial hypercholesterolemia 11. Type I Diabetes Mellitus (DM) 12. Use of concomitant medications (cyclosporin, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concern 13. Recent ongoing inter-current infection/high sensitivity C-Reactive Protein (hsCRP) greater than 10 mg/L 14. Active liver disease or hepatic dysfunction (defined as Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Gamma-Glutamyl Transferase [GGT], alkaline phosphate or bilirubin levels greater than or equal to 1.5 the upper limit of normal) 15. Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins 16. Patients having history suggestive of myalgia/myositis/arthralgia 17. Serious or unstable medical or psychological condition that could compromise the patient?s safety or successful trial participation 18. History of alcohol consumption greater than 2 drinks/day (30 ml) or 10 drinks per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in total cholesterol 2. Mean change in LDL cholesterol 3. Mean change in High Density Lipoprotein (HDL) cholesterol 4. Mean change in triglycerides 5. Number of patients achieving ATP III target LDL of less than 100 mg/dl Primary and secondary time points will be measured by evaluating the blood parameters on week 6 and week 12 against the baseline collected at the time of enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in the level of hs-CRP 2. Mean change in level of apoprotein B 3. Mean change in apoB/apoA1 ratio 4. Mean change in apoprotein A1 5. Mean change in lipoprotein a 6. Change in glycosylated haemoglobin at the end of study period 7. Incidence of hepatic dysfunction defined by liver enzyme elevation more than three times in the absence of other systemic cause 8. Compliance and side effects 9. Mean change in the level of creatinine kinase Primary and secondary time points will be measured by evaluating the blood parameters on week 6 and week 12 against the baseline collected at the time of enrolment. | — |
Countries
India
Outcome results
None listed