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

Study Overview
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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.

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.

Official Title
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Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia: A Randomized Crossover Trial

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Treatment of pitavastatin 4 mg qd for 12 weeks
* Behavioral: Life-style modification


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin treatment<br>Treatment of pitavastatin 4 mg qd for 12 weeks | Drug: Treatment of pitavastatin 4 mg qd for 12 weeks<br>* Treatment of pitavastatin 4 mg qd for 12 weeks<br>|
| Active Comparator: Life-style modification<br> | Behavioral: Life-style modification<br>* Nutritional support with the meal less than 65% of carbohydrate, less than 30% of fat. Exercise 3-4 times, 30 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Lgi3 level |  | At 12 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia