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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510588
First Posted: August 2, 2007
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig
August 1, 2007
August 2, 2007
December 3, 2014
July 2007
October 2013   (Final data collection date for primary outcome measure)
change in endothelial function in patients with stable coronary artery disease [ Time Frame: 6 months ]
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 ]
change in metabolic parameters
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Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
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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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
120
October 2013
October 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 %
Sexes Eligible for Study: Male
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00510588
0815-2007
Not Provided
Not Provided
Not Provided
Robert Hoellriegel, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Gerhard Schuler, Prof. of medicine Heartcenter Leipzig GmbH
University of Leipzig
December 2014

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