Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Apr 2004
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedAugust 29, 2011
August 1, 2011
2.2 years
August 23, 2011
August 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
NF-kappa B binding activity
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 Outcomes (1)
Inflammatory markers
up to 5 years
Study Arms (3)
Placebo
PLACEBO COMPARATORTreatment with placebo over 8 weeks
Simvastatin 80 mg
ACTIVE COMPARATORtreatment with 80 mg of simvastatin over 8 weeks
Sim10/Eze10
ACTIVE COMPARATORtreatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks
Interventions
treatment with 80 mg of simvastatin over a period of 8 weeks
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- refused informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Heidelberg
Heidelberg, 69120, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gottfried Rudofsky, MD
University Hospital of Heidelberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 29, 2011
Study Start
April 1, 2004
Primary Completion
July 1, 2006
Study Completion
August 1, 2011
Last Updated
August 29, 2011
Record last verified: 2011-08