Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia

Not Applicable

Completed

• Conditions: Dyslipidemias
• Interventions: Behavioral: Life-style modification; Drug: Treatment of pitavastatin 4 mg qd for 12 weeks

• Registration Number: NCT03730038
• Lead Sponsor: Yonsei University

Brief Summary

Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. Thus, in this study, we sought to demonstrate that the treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of Lgi3 in atherosclerosis.

Detailed Description

Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-05
• Study Start: 2019-02-18
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 20-80 years
• Patients with intermediate or low cardiovascular risks needing the statin treatment
• Patients with intermediate or low cardiovascular risks treating the statin treatment

Exclusion Criteria

• Patients without signed informed consent
• Patients with myopathy
• Pregnant women or women with potential childbearing
• Patients with diabetes
• Patients with established coronary artery disease
• Patients with heart failure
• Life expectancy less than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Life-style modification	Life-style modification	-
Pitavastatin treatment	Treatment of pitavastatin 4 mg qd for 12 weeks	Treatment of pitavastatin 4 mg qd for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in Lgi3 level	At 12 weeks after intervention

Trial Locations

Locations (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of