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

This study has been terminated.
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig Identifier:
First received: August 1, 2007
Last updated: December 2, 2014
Last verified: December 2014
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 Intervention
Severe Coronary Artery Disease
Impaired Glucose Tolerance
Other: exercise training
Other: exercise training + metformin
Other: exercise training + glitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University of Leipzig:

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

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

Enrollment: 29
Study Start Date: July 2007
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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%
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Robert Hoellriegel, Co-Investigator, University of Leipzig Identifier: NCT00510705     History of Changes
Other Study ID Numbers: 0816-2007
Study First Received: August 1, 2007
Last Updated: December 2, 2014

Keywords provided by 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 processed this record on May 23, 2017