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

NCT03730038 | Completed

• 1 other identifier: 4-2018-0794
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Changes in Lgi3 level

  At 12 weeks after intervention

Study Arms (2)

Pitavastatin treatment

EXPERIMENTAL

Treatment of pitavastatin 4 mg qd for 12 weeks

Drug: Treatment of pitavastatin 4 mg qd for 12 weeks

Life-style modification

ACTIVE COMPARATOR

Behavioral: Life-style modification

Interventions

Treatment of pitavastatin 4 mg qd for 12 weeks DRUG

Treatment of pitavastatin 4 mg qd for 12 weeks

Pitavastatin treatment

Life-style modification BEHAVIORAL

Nutritional support with the meal less than 65% of carbohydrate, less than 30% of fat. Exercise 3-4 times, 30 min

Life-style modification

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin, followed by wash-out period and life-style modification treatment. Patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment first, followed by wash-out period and pitavastatin treatment.

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: February 18, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

KR (1)