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

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. Identifier: NCT00510705
Recruitment Status : Terminated
First Posted : August 2, 2007
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig

Brief Summary:
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.

Condition or disease Intervention/treatment
Severe Coronary Artery Disease Obesity Impaired Glucose Tolerance Other: exercise training Other: exercise training + metformin Other: exercise training + glitazone

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2007
Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Regular physical exercise training alone
Other: exercise training
physical exercise training on a bicycle ergometer daily for 4 weeks
Regular physical exercise training + metformin
Other: exercise training + metformin
physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
Regular physical exercise training + glitazone
Other: exercise training + glitazone
physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
No Intervention: 4

Primary Outcome Measures :
  1. change in endothelial function in severe coronary artery disease [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. change in metabolic parameters [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510705

University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Gerhard Schuler, Prof. of Medicine Heartcenter Leipzig GmbH

Responsible Party: Robert Hoellriegel, Co-Investigator, University of Leipzig Identifier: NCT00510705     History of Changes
Other Study ID Numbers: 0816-2007
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Robert Hoellriegel, University of Leipzig:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs