Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease (KFO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00510588
First received: August 1, 2007
Last updated: July 25, 2013
Last verified: July 2013

August 1, 2007
July 25, 2013
July 2007
December 2013   (final data collection date for primary outcome measure)
change in endothelial function in patients with stable coronary artery disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in endothelial function in patients with stable coronary artery disease
Complete list of historical versions of study NCT00510588 on ClinicalTrials.gov Archive Site
change in metabolic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in metabolic parameters
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Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
Not Provided

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. Aim of the study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD and impaired glucose tolerance.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Stable Coronary Artery Disease
  • Obesity
  • Impaired Glucose Tolerance
  • Other: training
    regular physical exercise training for 6 months
  • Other: training + metformin
    regular physical exercise training in combination with metformin for 6 months
  • Other: training + glitazon
    regular physical exercise training in combination with a glitazon for 6 months
  • 1
    regular physical exercise training
    Intervention: Other: training
  • 2
    regular physical exercise training + metformin
    Intervention: Other: training + metformin
  • 3
    regular physical exercise training + glitazon
    Intervention: Other: training + glitazon
  • No Intervention: 4
    Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • either impaired glucose tolerance (2-h plasma glucose concentration >7.8 and <11.1 mmol/L during an oral glucose tolerance test) or impaired fasting glucose (fasting glucose concentration >6.0 and <7.0 mmol/L)
  • coronary artery disease determined by coronary angiography
  • BMI > 25
  • male patients aged 35-75 years

Exclusion Criteria:

  • diabetes mellitus type 1
  • diabetes mellitus type 2 in combination with glycosylates hemoglobin >6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration > 11.0 mmol/L
  • unstable angina pectoris
  • indication for coronary artery bypass graft operation
  • myocardial infarction within the last 3 months
  • reduced left-ventricular systolic function < 40 %
Male
35 Years to 75 Years
No
Contact: Axel Linke, MD 0049-341-8651672 linkea@medizin.uni-leipzig.de
Germany
 
NCT00510588
0815-2007
Not Provided
Robert Hoellriegel, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Gerhard Schuler, Prof. of medicine University of Leipzig
University of Leipzig
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP