NCT00510588CompletedNot Applicable
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
University of Leipzig2 sites in 1 country120 target enrollmentStarted: July 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- change in endothelial function in patients with stable coronary artery disease
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 %
Outcomes
Primary Outcomes
change in endothelial function in patients with stable coronary artery disease
Time Frame: 6 months
Secondary Outcomes
- change in metabolic parameters(6 months)
Investigators
Robert Hoellriegel
Co-Investigator
University of Leipzig
Study Sites (2)
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