Obesity Clinical Trial
— KFOChronic 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.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 75 Years |
Eligibility |
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 % |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | University of Leipzig - heart center | Leipzig |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in endothelial function in patients with stable coronary artery disease | 6 months | No | |
Secondary | change in metabolic parameters | 6 months | No |
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