Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02863185
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2016-08-01
Brief Title:
Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Sponsor:
Dong-A University
Organization:
Dong-A University
Study Overview
Official Title:
Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with chronic kidney disease CKD are high risk for death and cardiac disease is the major cause of death CKD patients commonly have traditional risk factors for coronary artery disease such as age gender hypertension cigarette smoking and dyslipidemia Previous studies have reported that reducing cholesterol levels is associated with reducing morbidity and mortality from atherosclerosis In particular pharmacologic treatment using statin has been decreased the risk of adverse cardiovascular events in CKD population Therefore guidelines recommended the use of statin in CKD patients On the other hands niacin or fibrates is not recommended concomitantly with statins in patients with CKD because of increased risk of adverse events In addition recent study has reported that there was no incremental clinical benefit from the addition of niacin to statin therapy in further decreasing the incidence of major cardiac events
Supplementation with omega-3 fatty acid FA lowers the risk of cardiovascular death in patients with myocardial infarction This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory anti-oxidative or anti-thrombic effects In addition omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid metabolism The erythrocyte membrane content of FA has been shown to correlated with the FA content of the myocardium The risk of cardiovascular disease is significantly reduced in patients with high omega-3 FA such as eicosapentanoic acid or docosahexaenoic acid DHA in the erythrocyte membrane In contrast high levels of erythrocyte membrane total trans-FA trans-oleic acid and arachidonic acid AA are associated with an increased risk of cardiovascular disease Erythrocyte membrane monounsaturated FA MUFA content including oleic acid is significantly higher in patients with acute coronary syndrome than control subjects The erythrocyte membrane oleic acid content was also higher in dialysis patients who have high risks of cardiovascular disease compared to control subjects Therefore the modification of erythrocyte membrane FA content is very important with respect to cardiovascular disease In a previous study erythrocyte membrane omega-3 FA was shown to be increased and the MUFA content was decreased after omega-3 FA supplementation in HD patients However there are no reports about the effect of statin on the erythrocyte membrane FA composition in CKD Recent study has reported that those with pitavastatin 4mg were decreased DHA to AA ratio but those with pravastatin 20 mg were not change the DHA to AA ratio in patient with CAD Statin may have important role on the modulation of erythrocyte membrane FA In this study the investigators hypothesized that pitavastatin supplementation can modify erythrocyte membrane FA content including MUFA and oleic acid in CKD patients In addition the investigators evaluated the effect of pitavastatin on adiponectin and glucose level in CKD patients
Supplementation with omega-3 fatty acid FA lowers the risk of cardiovascular death in patients with myocardial infarction This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory anti-oxidative or anti-thrombic effects In addition omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid metabolism The erythrocyte membrane content of FA has been shown to correlated with the FA content of the myocardium The risk of cardiovascular disease is significantly reduced in patients with high omega-3 FA such as eicosapentanoic acid or docosahexaenoic acid DHA in the erythrocyte membrane In contrast high levels of erythrocyte membrane total trans-FA trans-oleic acid and arachidonic acid AA are associated with an increased risk of cardiovascular disease Erythrocyte membrane monounsaturated FA MUFA content including oleic acid is significantly higher in patients with acute coronary syndrome than control subjects The erythrocyte membrane oleic acid content was also higher in dialysis patients who have high risks of cardiovascular disease compared to control subjects Therefore the modification of erythrocyte membrane FA content is very important with respect to cardiovascular disease In a previous study erythrocyte membrane omega-3 FA was shown to be increased and the MUFA content was decreased after omega-3 FA supplementation in HD patients However there are no reports about the effect of statin on the erythrocyte membrane FA composition in CKD Recent study has reported that those with pitavastatin 4mg were decreased DHA to AA ratio but those with pravastatin 20 mg were not change the DHA to AA ratio in patient with CAD Statin may have important role on the modulation of erythrocyte membrane FA In this study the investigators hypothesized that pitavastatin supplementation can modify erythrocyte membrane FA content including MUFA and oleic acid in CKD patients In addition the investigators evaluated the effect of pitavastatin on adiponectin and glucose level in CKD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None