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

August 25, 2011 updated by: Gottfried Rudofsky, Heidelberg University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SimEze

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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