Clinical trial NCT00874757: Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects
Official title: Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Statins, anti-inflammatory
Healthy subjects study
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 healthy subjects

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toll-like Receptor 4 Expression Pre- and Post-Treatment
timeFrame: Before and after three weeks of treatment with rosuvastatin
Secondary outcomes:
measure: Tumor Necrosis Factor (TNF)
timeFrame: Pre and post 3 weeks of rosuvastatin treatment
measure: Interleukin-6
timeFrame: Before (baseline) and after 3 weeks of rosuvastatin treatment
measure: Interleukin-8
timeFrame: measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, College of Pharmacy
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Timothy R McGuire, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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