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

Not Applicable

Terminated

• Conditions: Severe Coronary Artery Disease; Obesity; Impaired Glucose Tolerance
• Interventions: Other: exercise training + metformin; Other: exercise training; Other: exercise training + glitazone

• Registration Number: NCT00510705
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Primary Completion: 2012-07
• Status Verified: 2014-12
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 29

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	exercise training + metformin	Regular physical exercise training + metformin
1	exercise training	Regular physical exercise training alone
3	exercise training + glitazone	Regular physical exercise training + glitazone

Primary Outcome Measures

Name	Time	Method
change in endothelial function in severe coronary artery disease	4 weeks

Secondary Outcome Measures

Name	Time	Method
change in metabolic parameters	4 weeks

Trial Locations

Locations (1)

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Germany