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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01424891

Enrollment

Registered

2011-08-29

Start date

2004-04-30

Completion date

2011-08-31

Last updated

2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes, Inflammation

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.

Interventions

DRUGSimvastatin 80 mg

treatment with 80 mg of simvastatin over a period of 8 weeks

DRUGSim10/Eze10

treatment with combination of simvastatin 10 mg and ezetimibe 10 mg

DRUGPlacebo

treatment with placebo over 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026