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

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT02185963
• Lead Sponsor: Seoul National University Bundang Hospital

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)

Study Timeline

• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Study Start: 2014-10
• Primary Completion: 2015-12
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of