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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03730038
Enrollment
50
Registered
2018-11-05
Start date
2019-02-18
Completion date
2020-02-13
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Keywords

Dyslipidemia

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.

Interventions

DRUGTreatment of pitavastatin 4 mg qd for 12 weeks

Treatment of pitavastatin 4 mg qd for 12 weeks

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in Lgi3 levelAt 12 weeks after intervention

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026