- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185963
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With 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.
Study Overview
Detailed Description
- 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)
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin
Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors
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Rosuvastatin 20mg once a daily for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional HDL-C
Time Frame: 12 weeks
|
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-HDL-cholesterol = total cholesterol - HDL-C
Time Frame: 12 weeks
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12 weeks
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Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Soo Lim, PHD, Seoul National University Bundang Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- SNUBH_ENDO05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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