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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424891
• Other study ID #: SimEze
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: August 25, 2011
• Start date: April 2004
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2011
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Type 2 Diabetes

Intervention

Drug:
• Simvastatin 80 mg
treatment with 80 mg of simvastatin over a period of 8 weeks
• Sim10/Eze10
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
• Placebo
treatment with placebo over 8 weeks

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	No