Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease

Not Applicable

Completed

• Conditions: Stable Coronary Artery Disease; Obesity; Impaired Glucose Tolerance
• Interventions: Other: training + glitazon; Other: training; Other: training + metformin

• Registration Number: NCT00510588
• 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. Aim of the 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 (Glitazon or Metformin) in obese patients with stable 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: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• either impaired glucose tolerance (2-h plasma glucose concentration >7.8 and <11.1 mmol/L during an oral glucose tolerance test) or impaired fasting glucose (fasting glucose concentration >6.0 and <7.0 mmol/L)
• coronary artery disease determined by coronary angiography
• BMI > 25
• male patients aged 35-75 years

Exclusion Criteria

• diabetes mellitus type 1
• diabetes mellitus type 2 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
• indication for coronary artery bypass graft operation
• myocardial infarction within the last 3 months
• reduced left-ventricular systolic function < 40 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	training + glitazon	regular physical exercise training + glitazon
1	training	regular physical exercise training
2	training + metformin	regular physical exercise training + metformin

Primary Outcome Measures

Name	Time	Method
change in endothelial function in patients with stable coronary artery disease	6 months

Secondary Outcome Measures

Name	Time	Method
change in metabolic parameters	6 months

Trial Locations

Locations (1)

University of Leipzig - heart center; 🇩🇪 Leipzig, Germany