Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes

Study Overview
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Brief Summary
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The patients who have achieved LDL-C levels below the currently recommended targets may still experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD), raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether functional HDL is more important than total circulating levels of HDL-C in reducing CHD. Actually, the increased concentration of HDL alone might be ineffective indicating that qualitative changes in HDL levels in response to drug interventions are required to result in clinical benefit. The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.

Detailed Description
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Study design Study subject Number of Subjects (N = 30) Study outcome Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)

Official Title
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Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes HbA1c ≥ 7.5% Age ≥ 30 low HDL-C (<40 mg/dl in men or <50 mg/dl in women) and having 1 or more risk factors: 1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family history of CHD. Exclusion Criteria: Contraindication to rosuvastatin Pregnant or breast feeding women Reproductive-age women who refuse contraception Type 1 diabetes, gestational diabetes, or diabetes with secondary cause Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal) Renal failure (Cr > 2.0) Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) Not appropriate for lipid lowering treatment Medications which affect glycemic control Diseases which affect efficacy and safety of statin Other clinical trial within 30 days

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors | Drug: Rosuvastatin<br>* Rosuvastatin 20mg once a daily for 12 weeks<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional HDL-C | Cholesterol efflux from macrophages LDL-induced monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-HDL-cholesterol = total cholesterol - HDL-C |  | 12 weeks | 
| Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Dyslipidemia, HDL function, Cholesterol efflux, MCA assay, MCP-1