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

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ClinicalTrials.gov Identifier: NCT00510588
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Robert Hoellriegel, 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.

Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Obesity Impaired Glucose Tolerance Other: training Other: training + metformin Other: training + glitazon Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
regular physical exercise training
Other: training
regular physical exercise training for 6 months

2
regular physical exercise training + metformin
Other: training + metformin
regular physical exercise training in combination with metformin for 6 months

3
regular physical exercise training + glitazon
Other: training + glitazon
regular physical exercise training in combination with a glitazon for 6 months

No Intervention: 4
Control



Primary Outcome Measures :
  1. change in endothelial function in patients with stable coronary artery disease [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in metabolic parameters [ Time Frame: 6 months ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 %

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510588


Locations
Germany
University of Leipzig - heart center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Gerhard Schuler, Prof. of medicine Heart Center Leipzig - University Hospital

Responsible Party: Robert Hoellriegel, Co-Investigator, University of Leipzig
ClinicalTrials.gov Identifier: NCT00510588     History of Changes
Other Study ID Numbers: 0815-2007
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Robert Hoellriegel, University of Leipzig:
adiposity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs