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

Obesity Clinical Trial

— KFO  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00510705
• Other study ID #: 0816-2007
• Status: Terminated
• Phase: N/A
• Start date: July 2007

Study information

• Verified date: December 2014
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Glucose Intolerance
• Impaired Glucose Tolerance
• Myocardial Ischemia
• Obesity
• Severe Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in endothelial function in severe coronary artery disease		4 weeks
Secondary	change in metabolic parameters		4 weeks