Clinical trial NCT02185963: Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes
Official title: Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Dyslipidemia
HDL function
Cholesterol efflux
MCA assay
MCP-1
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Functional HDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Non-HDL-cholesterol = total cholesterol - HDL-C
timeFrame: 12 weeks
measure: Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KM, Jung KY, Yun HM, Lee SY, Oh TJ, Jang HC, Lim S. Effect of rosuvastatin on fasting and postprandial endothelial biomarker levels and microvascular reactivity in patients with type 2 diabetes and dyslipidemia: a preliminary report. Cardiovasc Diabetol. 2017 Nov 9;16(1):146. doi: 10.1186/s12933-017-0629-0.