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Completed

NCT Number: NCT01424891

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simvastatin 80 mg

Drug

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

Other names: zocor, simvastatin

Sim10/Eze10

Drug

treatment with combination of simvastatin 10 mg and ezetimibe 10 mg

Other names: inegy

Placebo

Drug

treatment with placebo over 8 weeks

Primary outcomes

  1. NF-kappa B binding activity

    Time frame: 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 outcomes

  1. Inflammatory markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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