HealthyNCT00874757
Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects
An observational study of Healthy, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2010to 1 Sep 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 20 healthy subjects
Who may be able to join
- Healthy male non-asian subjects
Who cannot join
- Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Pharmacy
Omaha, Nebraska, 68198-6045
About this study
Official title: Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Rosuvastatin
- Keywords
- Statins, anti-inflammatory, Healthy subjects study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre- and post- rosuvastatin treatment.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre and post rosuvastatin treatment. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toll-like Receptor 4 Expression Pre- and Post-Treatment
Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.
Measured: Before and after three weeks of treatment with rosuvastatin
Secondary outcomes (3)
Tumor Necrosis Factor (TNF)
Inflammatory cytokine generated after treatment of whole blood collected before and after rosuvastatin treatment
Measured: Pre and post 3 weeks of rosuvastatin treatment
Interleukin-6
Interleukin-6 inflammatory cytokine which will be released after LPS treatment of blood
Measured: Before (baseline) and after 3 weeks of rosuvastatin treatment
Interleukin-8
Interleukin-8 an inflammatory cytokine which will be releases after LPS treatment.
Measured: measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study start15 Nov 2010
- Primary completion1 Sep 2011
- Study completion1 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy R McGuire, PharmD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874757
- Sponsor's protocol ID
- 0088-09-FB
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2009
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wickelgren I. Immunology. Targeting the tolls. Science. 2006 Apr 14;312(5771):184-7. doi: 10.1126/science.312.5771.184. No abstract available.
PubMed 16614188Falagas ME, Makris GC, Matthaiou DK, Rafailidis PI. Statins for infection and sepsis: a systematic review of the clinical evidence. J Antimicrob Chemother. 2008 Apr;61(4):774-85. doi: 10.1093/jac/dkn019. Epub 2008 Feb 7.
PubMed 18263570Niessner A, Steiner S, Speidl WS, Pleiner J, Seidinger D, Maurer G, Goronzy JJ, Weyand CM, Kopp CW, Huber K, Wolzt M, Wojta J. Simvastatin suppresses endotoxin-induced upregulation of toll-like receptors 4 and 2 in vivo. Atherosclerosis. 2006 Dec;189(2):408-13. doi: 10.1016/j.atherosclerosis.2005.12.022. Epub 2006 Jan 26.
PubMed 16443229Novack V, Eisinger M, Frenkel A, Terblanche M, Adhikari NK, Douvdevani A, Amichay D, Almog Y. The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial. Intensive Care Med. 2009 Jul;35(7):1255-60. doi: 10.1007/s00134-009-1429-0. Epub 2009 Feb 11.
PubMed 19205663Wang CY, Liu PY, Liao JK. Pleiotropic effects of statin therapy: molecular mechanisms and clinical results. Trends Mol Med. 2008 Jan;14(1):37-44. doi: 10.1016/j.molmed.2007.11.004.
PubMed 18068482
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of
- ClinicalTrials.gov ID
- NCT00874757
- Acronym / sponsor ID
- 0088-09-FB
- Conditions
- Healthy
- Keywords
- Statins, anti-inflammatory, Healthy subjects study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Nov 2010 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Sep 2011 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | – | Drug: RosuvastatinHealthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre and post rosuvastatin treatment. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 healthy subjects
Key inclusion criteria (1 listed)
- Healthy male non-asian subjects
Key exclusion criteria (1 listed)
- Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorHealthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre- and post- rosuvastatin treatment. | Drug | Rosuvastatin |
Primary outcome
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.
3 secondary outcomes
Tumor Necrosis Factor (TNF)
Time frame: Pre and post 3 weeks of rosuvastatin treatment
Interleukin-6
Time frame: Before (baseline) and after 3 weeks of rosuvastatin treatment
Interleukin-8
Time frame: measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16614188Wickelgren I. Immunology. Targeting the tolls. Science. 2006 Apr 14;312(5771):184-7. doi: 10.1126/science.312.5771.184. No abstract available.
- Background: PubMed 18263570Falagas ME, Makris GC, Matthaiou DK, Rafailidis PI. Statins for infection and sepsis: a systematic review of the clinical evidence. J Antimicrob Chemother. 2008 Apr;61(4):774-85. doi: 10.1093/jac/dkn019. Epub 2008 Feb 7.
- Background: PubMed 16443229Niessner A, Steiner S, Speidl WS, Pleiner J, Seidinger D, Maurer G, Goronzy JJ, Weyand CM, Kopp CW, Huber K, Wolzt M, Wojta J. Simvastatin suppresses endotoxin-induced upregulation of toll-like receptors 4 and 2 in vivo. Atherosclerosis. 2006 Dec;189(2):408-13. doi: 10.1016/j.atherosclerosis.2005.12.022. Epub 2006 Jan 26.
- Background: PubMed 19205663Novack V, Eisinger M, Frenkel A, Terblanche M, Adhikari NK, Douvdevani A, Amichay D, Almog Y. The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial. Intensive Care Med. 2009 Jul;35(7):1255-60. doi: 10.1007/s00134-009-1429-0. Epub 2009 Feb 11.
- Background: PubMed 18068482Wang CY, Liu PY, Liao JK. Pleiotropic effects of statin therapy: molecular mechanisms and clinical results. Trends Mol Med. 2008 Jan;14(1):37-44. doi: 10.1016/j.molmed.2007.11.004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R McGuire, PharmD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toll-like Receptor 4 Expression Pre- and Post-Treatment (time frame: Before and after three weeks of treatment with rosuvastatin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874757, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.