Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital Identifier:
First received: July 7, 2014
Last updated: October 11, 2014
Last verified: October 2014

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.

Condition Intervention Phase
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Functional HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Non-HDL-cholesterol = total cholesterol - HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors
Drug: Rosuvastatin
Rosuvastatin 20mg once a daily for 12 weeks
Other Name: Crestor

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)

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02185963

Contact: Soo Lim, PHD +82-31-787-7035

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Soo Lim, PHD    +/2-31-787-7035   
Sub-Investigator: KyongYeun Jung, MD         
Sub-Investigator: Eu Jeong Ku, MD         
Sub-Investigator: EunKyoung Seong         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Principal Investigator: Soo Lim, PHD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital Identifier: NCT02185963     History of Changes
Other Study ID Numbers: SNUBH_ENDO05
Study First Received: July 7, 2014
Last Updated: October 11, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
HDL function
Cholesterol efflux
MCA assay

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015