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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Treatment with placebo over 8 weeks |
|
| Simvastatin 80 mg | Active Comparator | treatment with 80 mg of simvastatin over 8 weeks |
|
| Sim10/Eze10 | Active Comparator | treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 80 mg | Drug | treatment with 80 mg of simvastatin over a period of 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gottfried Rudofsky, MD | University Hospital of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Heidelberg | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Sim10/Eze10 | Drug | treatment with combination of simvastatin 10 mg and ezetimibe 10 mg |
|
|
| Placebo | Drug | treatment with placebo over 8 weeks |
|
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |