Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295373
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2006-02-21
Brief Title:
Exercise And Rosuvastatin Treatment Is There an Anti-Inflammatory Synergy
Sponsor:
Purdue University
Organization:
Purdue University
Study Overview
Official Title:
Phase 4 Clinical Trial to Examine the Role of Rosuvastatin and Exercise Treatment in Modulating Inflammatory Response in Hypercholesterolemic Subjects
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to determine whether the effects of rosuvastatin treatment and exercise training can be synergistic with respect to the innate immune receptor TLR4 markers of systemic inflammation and stimulated production of inflammatory cytokines in hypercholesterolemic subjects It is hypothesized that a rosuvastatin and exercise intervention will synergistically lower measured variables so as to be anti-inflammatory
Detailed Description:
Both statin drugs and exercise training are known to exert anti-inflammatory effects We found that both high levels of physical activity and an exercise training program reduced markers of inflammation and lowered monocyte Toll-like receptor 4 TLR4 expression It has not been determined whether statins exert their anti-inflammatory effects through the toll-like receptors or whether combined statinexercise treatment will exert synergistic anti-inflammatory effects Thus the primary purposes of this study are two-fold 1 Determine whether rosuvastatin treatment downregulates LPS-induced inflammatory responses serum hsCRP and monocyte TLR4 expression in hypercholesterolemic patients and 2 Determine whether adding exercise training to rosuvastatin treatment induces an anti-inflammatory synergy and further lowers LPS-induced inflammatory response hsCRP and TLR4 expression Thirty two hypercholesterolemic total cholesterol 200 mgdL LDL 130 mgdL will be randomly divided into two groups statin ST and statin and exercise STE Sixteen physically active no-statin subjects will also be recruited as a control groupCON After baseline blood sampling ST and STE groups will begin a 10-week course of rosuvastatin calcium treatment 10 mgd after which a second blood sample will be obtained The STE group will then begin a 10 week three days per week combined endurance 20 min at 70 of heart rate reserve and resistive training 2 sets of 10 upper- and lower-body exercises program The ST group will not exercise and both STE and ST groups will continue taking their medication as prescribed A final blood sample will be taken at the end of this 10-week segment Blood samples will also be taken from the CON group at 0 10 and 20 weeks Monocyte expression of TLR4 CD14 LPS receptor and CD16 monocyte maturation marker will be assessed using flow cytometry LPS-stimulated inflammatory cytokine production and serum levels of hsCRP TNF-a oxLDL LDL HDL endotoxin LPS binding protein and sCD14 will also be measured at each time point baseline 10 weeks 20 weeks These experiments will allow us to determine whether rosuvastatin downregulates TLR4 an important mediator of inflammation and whether exercise known to lower TLR4 expression can augment the rosuvastatin effects Regular exercise and statin treatment are known to reduce disease risk but the benefits of these treatments is infrequently attributed to their anti-inflammatory effects It is important to document mechanisms of anti-inflammatory action for exercise training and statin treatment and to determining whether these treatments have combined beneficial effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB Protocol Ref 0504001888 | None | None | None |