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NCT Number: NCT02185963

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

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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Key information

Conditions

Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

About this study

  • Study design Study subject Number of Subjects (N = 30)
  • Study outcome

Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes
  • HbA1c ≥ 7.5%
  • Age ≥ 30
  • 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

  • Contraindication to rosuvastatin
  • Pregnant or breast feeding women
  • Reproductive-age women who refuse contraception
  • Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
  • Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
  • Renal failure (Cr > 2.0)
  • Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)
  • Not appropriate for lipid lowering treatment
  • Medications which affect glycemic control
  • Diseases which affect efficacy and safety of statin
  • Other clinical trial within 30 days

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 20mg once a daily for 12 weeks

Other names: Crestor

Primary outcomes

  1. Functional HDL-C

    Time frame: 12 weeks

    • Cholesterol efflux from macrophages
    • LDL-induced monocyte chemotactic activity (MCA) Assay
    • Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)

Secondary outcomes

  1. Non-HDL-cholesterol = total cholesterol - HDL-C

    Time frame: 12 weeks

  2. Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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