Diabetes
Conditions
Keywords
Diabetes, Dyslipidemia, HDL function, Cholesterol efflux, MCA assay, MCP-1
Brief summary
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
1. Study design Study subject Number of Subjects (N = 30) 2. Study outcome Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol 3. 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)
Interventions
DRUGRosuvastatin
Rosuvastatin 20mg once a daily for 12 weeks
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. HbA1c ≥ 7.5% 3. Age ≥ 30 4. 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
1. Contraindication to rosuvastatin 2. Pregnant or breast feeding women 3. Reproductive-age women who refuse contraception 4. Type 1 diabetes, gestational diabetes, or diabetes with secondary cause 5. Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal) 6. Renal failure (Cr \> 2.0) 7. Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) 8. Not appropriate for lipid lowering treatment 9. Medications which affect glycemic control 10. Diseases which affect efficacy and safety of statin 11. Other clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional HDL-C | 12 weeks | 1. Cholesterol efflux from macrophages 2. LDL-induced monocyte chemotactic activity (MCA) Assay 3. Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1) |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed