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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2020-02-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pitavastatin treatment

Treatment of pitavastatin 4 mg qd for 12 weeks

Group Type EXPERIMENTAL

Treatment of pitavastatin 4 mg qd for 12 weeks

Intervention Type DRUG

Treatment of pitavastatin 4 mg qd for 12 weeks

Life-style modification

Group Type ACTIVE_COMPARATOR

Life-style modification

Intervention Type BEHAVIORAL

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

Interventions

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Treatment of pitavastatin 4 mg qd for 12 weeks

Intervention Type DRUG

Life-style modification

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No