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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

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.

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Detailed Description

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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)

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 20mg once a daily for 12 weeks

Interventions

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Rosuvastatin

Rosuvastatin 20mg once a daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No