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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01424891
Collaborator
(none)
31
Enrollment
1
Location
3
Arms
88
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Apr 1, 2004
Actual Primary Completion Date :
Jul 1, 2006
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

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 Names:
  • inegy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. NF-kappa B binding activity [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Heidelberg Heidelberg Germany 69120

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Principal Investigator: Gottfried Rudofsky, MD, University Hospital of Heidelberg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gottfried Rudofsky, Principal investigator, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01424891
    Other Study ID Numbers:
    • SimEze
    First Posted:
    Aug 29, 2011
    Last Update Posted:
    Aug 29, 2011
    Last Verified:
    Aug 1, 2011
    Additional relevant MeSH terms:
    Inflammation
    Simvastatin

    Study Results

    No Results Posted as of Aug 29, 2011