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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Inflammation
• Interventions: Drug: Placebo; Drug: Simvastatin 80 mg; Drug: Sim10/Eze10

• Registration Number: NCT01424891
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-07
• Status Verified: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment with placebo over 8 weeks
Simvastatin 80 mg	Simvastatin 80 mg	treatment with 80 mg of simvastatin over 8 weeks
Sim10/Eze10	Sim10/Eze10	treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital of Heidelberg; 🇩🇪 Heidelberg, Germany