NCT00295373

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

February 21, 2006

Last Update Submit

April 19, 2007

Conditions

Nonfamilial HypercholesterolemiaPhysical Inactivity

Keywords

HypercholesterolemiaExerciseStatinRosuvastatinTLR4Inflammation

Outcome Measures

Primary Outcomes (6)

  • The following measures will be made at 0, 10 and 20 weeks:

  • Monocyte cell-surface expression of TLR4, CD14, and CD16

  • LPS-stimulated whole blood production of IL-6 and TNF-α

  • Serum levels of hsCRP and TNF-α

  • Serum levels of Endotoxin LDL, OxLDL, HDL, sCD14, and

  • Lipopolysaccharide Binding Protein.

Secondary Outcomes (3)

  • Creatine kinase & ALT (0, 5, 10 weeks; rosuvastatin group)

  • Creatine kinase & ALT (48hrs after 1st and 5th exercise

  • bout; rosuvastatin + exercise group)

Interventions

RosuvastatinDRUG
Exercise TrainingBEHAVIORAL

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonfamilial hypercholesterolemia
  • Total cholesterol \>200 mg/dl, LDL \>130 mg/dL
  • Physical inactivity
  • Moderate to low alcohol intake

You may not qualify if:

  • Liver or kidney disease
  • Acute illness or infection
  • Use of corticosteroids, ACE inhibitors, platelet aggregating inhibitors, thiazolidinediones, and bis-phosphonates.
  • Use of cyclosporine, warfarin, gemfibrozil or other lipid lowering agents
  • Regular antacid or aspirin use
  • Type I \& II diabetes with insulin treatment
  • hypothyroidism, and/or renal insufficiency
  • Chronic/debilitating osteoarthritis
  • Rheumatoid arthritis
  • Central or peripheral nervous system disorders
  • Anti-depressant medications
  • Major affective disorder
  • HIV infection or auto-immune disorders
  • Use of tobacco products
  • unexplained or intended weight loss of \> 2 kg during the previous six months
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Related Publications (3)

  • Stewart LK, Flynn MG, Campbell WW, Craig BA, Robinson JP, McFarlin BK, Timmerman KL, Coen PM, Felker J, Talbert E. Influence of exercise training and age on CD14+ cell-surface expression of toll-like receptor 2 and 4. Brain Behav Immun. 2005 Sep;19(5):389-97. doi: 10.1016/j.bbi.2005.04.003.

    PMID: 15963685BACKGROUND

  • McFarlin BK, Flynn MG, Campbell WW, Stewart LK, Timmerman KL. TLR4 is lower in resistance-trained older women and related to inflammatory cytokines. Med Sci Sports Exerc. 2004 Nov;36(11):1876-83. doi: 10.1249/01.mss.0000145465.71269.10.

    PMID: 15514501BACKGROUND

  • Methe H, Kim JO, Kofler S, Nabauer M, Weis M. Statins decrease Toll-like receptor 4 expression and downstream signaling in human CD14+ monocytes. Arterioscler Thromb Vasc Biol. 2005 Jul;25(7):1439-45. doi: 10.1161/01.ATV.0000168410.44722.86. Epub 2005 Apr 28.

    PMID: 15860745BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorHypercholesterolemiaMotor ActivityInflammation

Interventions

Rosuvastatin CalciumExercise

Condition Hierarchy (Ancestors)

BehaviorHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert E Hannemann, MD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Michael G Flynn, PhD

    Purdue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

February 1, 2006

Study Completion

August 1, 2007

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

US(1)