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Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

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ClinicalTrials.gov Identifier: NCT01424891
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Sponsor:
Information provided by (Responsible Party):
Gottfried Rudofsky, University of Heidelberg

Brief Summary:
Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Inflammation Drug: Simvastatin 80 mg Drug: Sim10/Eze10 Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Study Start Date : April 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Treatment with placebo over 8 weeks
Drug: Placebo
treatment with placebo over 8 weeks
Active Comparator: Simvastatin 80 mg
treatment with 80 mg of simvastatin over 8 weeks
Drug: Simvastatin 80 mg
treatment with 80 mg of simvastatin over a period of 8 weeks
Other Names:
  • zocor
  • simvastatin
Active Comparator: Sim10/Eze10
treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks
Drug: Sim10/Eze10
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Other Name: inegy



Primary Outcome Measures :
  1. NF-kappa B binding activity [ Time Frame: up to 5 years ]
    The binding activity of nuclear transcription factor nuclear factor kappa B (NF-kappa B)will be measured in patients with type 2 diabetes before and after 8 weeks while under study treatment. Analysis will be done with electrophoretic mobility shift assay. Nuclear extract, which is necessary, will be generated from peripheral blood mononuclear cells.


Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: up to 5 years ]
    Blood levels of high sensitivity CRP and interleukin-6 will be measured before study start and after 8 weeks while under study medication.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 35 to 80 years old
  • type 2 diabetes
  • HbA1c value between 6.0 % and 9.0 %
  • elevated LDL-c values > 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion Criteria:

  • refused informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424891


Locations
Germany
University Hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Gottfried Rudofsky, MD University Hospital of Heidelberg

Responsible Party: Gottfried Rudofsky, Principal investigator, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01424891     History of Changes
Other Study ID Numbers: SimEze
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors