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OpenTrials
Completed

NCT Number: NCT00510588

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

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.

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Key information

Conditions

Stable Coronary Artery Disease Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig - heart center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

Training

Other

regular physical exercise training for 6 months

training + metformin

Other

regular physical exercise training in combination with metformin for 6 months

training + glitazon

Other

regular physical exercise training in combination with a glitazon for 6 months

Primary outcomes

  1. change in endothelial function in patients with stable coronary artery disease

    Time frame: 6 months

Secondary outcomes

  1. change in metabolic parameters

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Acronym: KFO

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2007
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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