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Completed

NCT Number: NCT03730038

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

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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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of pitavastatin 4 mg qd for 12 weeks

Drug

Treatment of pitavastatin 4 mg qd for 12 weeks

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

Primary outcomes

  1. Changes in Lgi3 level

    Time frame: At 12 weeks after intervention

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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