| Trial ID: | L2026 |
| Source ID: | NCT01424891
|
| Associated Drug: |
Simvastatin 80 Mg
|
| Title: |
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Inflammation
|
| Interventions: |
DRUG: Simvastatin 80 mg|DRUG: Sim10/Eze10|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Heidelberg University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-04
|
| Completion Date: |
2011-08
|
| Results First Posted: |
|
| Last Update Posted: |
2011-08-29
|
| Locations: |
University Hospital of Heidelberg, Heidelberg, 69120, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01424891
|
