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Clinical Trials/NCT00874757
NCT00874757CompletedNot Applicable

Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of

University of Nebraska1 site in 1 country20 target enrollmentStarted: November 15, 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Toll-like Receptor 4 Expression Pre- and Post-Treatment

Study Overview

Brief Summary

The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.

Detailed Description

After providing consent healthy subjects (N=20) completed a health and drug inventory questionnaire and had blood samples drawn to measure baseline electrolytes, kidney function, liver function, and creatine kinase to determine study eligibility. Blood samples were also collected to analyze baseline inflammatory markers (tlr-4 monocyte expression and cytokine production). Patients received 20 mg daily of rosuvastatin for 3 weeks followed by blood collection, and the measurement of inflammatory markers repeated. Whole blood samples were analyzed by flow-cytometry to determine percent expression of tlr-4 on monocytes which was the primary inflammatory marker for the study. Secondary inflammatory markers tumor necrosis factor (TNF), interleukin-6 (IL-6), and interleukin-8 (IL-8) were measured after blood was incubated ex-vivo with lipopolysaccharide (LPS) for 3 hours. LPS induction experiments were performed on blood from pre and post rosuvastatin treatment. Finally, blood lipid profiles (cholesterol, low density lipoprotein (LDL), very low-density lipoprotein (VLDL), and high density lipo protein (HDL), were assessed both pre and post rosuvastatin treatment. End of study (after 3 weeks of rosuvastatin treatment) electrolytes, kidney function, liver function, and creatine kinase (CK) were measured to determine any changes as a result of rosuvastatin treatment. In addition to pre and post safety assessment a phone call was made to evaluate rosuvastatin side effects at the midpoint of the three-week treatment period.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 39 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy male non-asian subjects

Exclusion Criteria

  • Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs

Arms & Interventions

Rosuvastatin

Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre and post rosuvastatin treatment.

Intervention: Rosuvastatin (Drug)

Outcomes

Primary Outcomes

Toll-like Receptor 4 Expression Pre- and Post-Treatment

Time Frame: Before and after three weeks of treatment with rosuvastatin

Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.

Secondary Outcomes

  • Interleukin-8(measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment)
  • Tumor Necrosis Factor (TNF)(Pre and post 3 weeks of rosuvastatin treatment)
  • Interleukin-6(Before (baseline) and after 3 weeks of rosuvastatin treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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