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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185963
• Other study ID #: SNUBH_ENDO05
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2014
• Last updated: May 2, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 20mg once a daily for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Non-HDL-cholesterol = total cholesterol - HDL-C		12 weeks	Yes
Secondary	Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women		12 weeks	Yes