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

University of Leipzig29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Severe Coronary Artery Disease Obesity Impaired Glucose Tolerance

Interventions

exercise trainingOTHER

physical exercise training on a bicycle ergometer daily for 4 weeks

exercise training + metforminOTHER

physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks

exercise training + glitazoneOTHER

physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks

Eligibility

Sex: MALEMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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%

Locations (1)

University of Leipzig - Heart Center

Leipzig, Germany

Outcomes

Primary Outcomes

change in endothelial function in severe coronary artery disease

Time frame: 4 weeks

Secondary Outcomes

change in metabolic parameters

Time frame: 4 weeks

Data from ClinicalTrials.gov

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