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

This study has been completed.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital Identifier:
First received: July 7, 2014
Last updated: May 2, 2016
Last verified: May 2016

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: 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 ]
    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 ]
  • Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women [ Time Frame: 12 weeks ]

Enrollment: 50
Study Start Date: October 2014
Study Completion Date: May 2016
Primary Completion Date: December 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT02185963

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
Principal Investigator: Soo Lim, PHD Seoul National University Bundang Hospital
  More Information

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: May 2, 2016

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on April 21, 2017