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

Study Overview
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Brief Summary
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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.

Conditions
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Severe Coronary Artery Disease, Obesity, Impaired Glucose Tolerance

Intervention / Treatment
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* Other: exercise training
* Other: exercise training + metformin
* Other: exercise training + glitazone


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Regular physical exercise training alone | Other: exercise training<br>* physical exercise training on a bicycle ergometer daily for 4 weeks<br>|
| Other: 2<br>Regular physical exercise training + metformin | Other: exercise training + metformin<br>* physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks<br>|
| Other: 3<br>Regular physical exercise training + glitazone | Other: exercise training + glitazone<br>* physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks<br>|
| No Intervention: 4<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in endothelial function in severe coronary artery disease |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in metabolic parameters |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adiposity