Status:
COMPLETED
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Diabetes
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief 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-...
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 Chol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02185963
Start Date
October 1 2014
End Date
May 1 2016
Last Update
May 3 2016
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea