Diabetic Dyslipidemia, Type 2 Diabetes
Conditions
Keywords
Statins administration in diabetic dyslipidemia
Brief summary
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.
Interventions
DRUGSimvastatin
20 mg/day in one oral administration
DRUGRosuvastatin
20 mg/day in one oral administration.
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes in good glycemic control, treated with metformin alone. * Untreated dyslipidemia. * BMI \<30.
Exclusion criteria
* History of cancer. * History of cardiovascular diseases. * Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose tolerance assessed by HbA1c and fasting glucose | 1, 6, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. | 1, 6, 12 months. |
Countries
Italy
Outcome results
None listed