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Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease (KFO)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00510705
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 severe coronary artery disease [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
change in endothelial function in severe coronary artery disease
Complete list of historical versions of study NCT00510705 on ClinicalTrials.gov Archive Site
change in metabolic parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
change in metabolic parameters
Not Provided
Not Provided
 
Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease
Not Provided

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this 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 (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Severe Coronary Artery Disease
  • Obesity
  • Impaired Glucose Tolerance
  • Other: exercise training
    physical exercise training on a bicycle ergometer daily for 4 weeks
  • Other: exercise training + metformin
    physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
  • Other: exercise training + glitazone
    physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
  • 1
    Regular physical exercise training alone
    Intervention: Other: exercise training
  • 2
    Regular physical exercise training + metformin
    Intervention: Other: exercise training + metformin
  • 3
    Regular physical exercise training + glitazone
    Intervention: Other: exercise training + glitazone
  • 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.
 
Terminated
29
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Either impaired glucose tolerance (2 hour plasma glucose concentration > 7.8 and < 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( > 6.0 and < 7.0 mmol/L)
  • Body mass index (BMI) > 25
  • Severe coronary artery disease determined by coronary angiography
  • Male patients aged 35-75 years

Exclusion Criteria:

  • Diabetes mellitus type I
  • Diabetes mellitus type II 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
  • Myocardial infarction within the last 4 weeks
  • Reduced left-ventricular systolic function < 30%
Male
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00510705
0816-2007
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