Back to resultsChronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease (KFO)
Primary Purpose
Stable Coronary Artery Disease, Obesity, Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
training
training + metformin
training + glitazon
Sponsored by
About this trial
This is an interventional prevention trial for Stable Coronary Artery Disease focused on measuring adiposity
Eligibility Criteria
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 %
Sites / Locations
- University of Leipzig - heart center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
No Intervention
Arm Label
1
2
3
4
Arm Description
regular physical exercise training
regular physical exercise training + metformin
regular physical exercise training + glitazon
Control
Outcomes
Primary Outcome Measures
change in endothelial function in patients with stable coronary artery disease
Secondary Outcome Measures
change in metabolic parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00510588
Brief Title
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
Acronym
KFO
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease, Obesity, Impaired Glucose Tolerance
Keywords
adiposity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
regular physical exercise training
Arm Title
2
Arm Type
Other
Arm Description
regular physical exercise training + metformin
Arm Title
3
Arm Type
Other
Arm Description
regular physical exercise training + glitazon
Arm Title
4
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
training
Intervention Description
regular physical exercise training for 6 months
Intervention Type
Other
Intervention Name(s)
training + metformin
Intervention Description
regular physical exercise training in combination with metformin for 6 months
Intervention Type
Other
Intervention Name(s)
training + glitazon
Intervention Description
regular physical exercise training in combination with a glitazon for 6 months
Primary Outcome Measure Information:
Title
change in endothelial function in patients with stable coronary artery disease
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in metabolic parameters
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 %
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, Prof. of medicine
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - heart center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
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