Back to resultsEffects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Treatment of pitavastatin 4 mg qd for 12 weeks
Life-style modification
Sponsored by
About this trial
This is an interventional other trial for Dyslipidemias focused on measuring Dyslipidemia
Eligibility Criteria
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
Sites / Locations
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pitavastatin treatment
Life-style modification
Arm Description
Treatment of pitavastatin 4 mg qd for 12 weeks
Outcomes
Primary Outcome Measures
Changes in Lgi3 level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03730038
Brief Title
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia
Official Title
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia: A Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Dyslipidemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin treatment
Arm Type
Experimental
Arm Description
Treatment of pitavastatin 4 mg qd for 12 weeks
Arm Title
Life-style modification
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Treatment of pitavastatin 4 mg qd for 12 weeks
Intervention Description
Treatment of pitavastatin 4 mg qd for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Life-style modification
Intervention Description
Nutritional support with the meal less than 65% of carbohydrate, less than 30% of fat. Exercise 3-4 times, 30 min
Primary Outcome Measure Information:
Title
Changes in Lgi3 level
Time Frame
At 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia
We'll reach out to this number within 24 hrs