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

Primary Purpose

Type 2 Diabetes, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Simvastatin 80 mg
Sim10/Eze10
Placebo
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Simvastatin 80 mg

Sim10/Eze10

Arm Description

Treatment with placebo over 8 weeks

treatment with 80 mg of simvastatin over 8 weeks

treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 23, 2011
Last Updated
August 25, 2011
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01424891
Brief Title
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Official Title
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo over 8 weeks
Arm Title
Simvastatin 80 mg
Arm Type
Active Comparator
Arm Description
treatment with 80 mg of simvastatin over 8 weeks
Arm Title
Sim10/Eze10
Arm Type
Active Comparator
Arm Description
treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks
Intervention Type
Drug
Intervention Name(s)
Simvastatin 80 mg
Other Intervention Name(s)
zocor, simvastatin
Intervention Description
treatment with 80 mg of simvastatin over a period of 8 weeks
Intervention Type
Drug
Intervention Name(s)
Sim10/Eze10
Other Intervention Name(s)
inegy
Intervention Description
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
treatment with placebo over 8 weeks
Primary Outcome Measure Information:
Title
NF-kappa B binding activity
Description
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.
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
Blood levels of high sensitivity CRP and interleukin-6 will be measured before study start and after 8 weeks while under study medication.
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gottfried Rudofsky, MD
Organizational Affiliation
University Hospital of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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