NCT02185963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

July 7, 2014

Last Update Submit

May 2, 2016

Conditions

Diabetes

Keywords

DiabetesDyslipidemiaHDL functionCholesterol effluxMCA assayMCP-1

Outcome Measures

Primary Outcomes (1)

  • Functional HDL-C

    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)

    12 weeks

Secondary Outcomes (2)

  • Non-HDL-cholesterol = total cholesterol - HDL-C

    12 weeks

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

    12 weeks

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

Rosuvastatin 20mg once a daily for 12 weeks

Also known as: Crestor
Rosuvastatin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29121934DERIVED

MeSH Terms

Conditions

Diabetes MellitusDyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soo Lim, PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

KR(1)