We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510588
First Posted: August 2, 2007
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Hoellriegel, University of Leipzig
  Purpose
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 Intervention
Stable Coronary Artery Disease Obesity Impaired Glucose Tolerance Other: training Other: training + metformin Other: training + glitazon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Robert Hoellriegel, University of Leipzig:

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

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

Enrollment: 120
Study Start Date: July 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
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 %
  Contacts and Locations
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 Heartcenter Leipzig GmbH
  More Information

Responsible Party: Robert Hoellriegel, Co-Investigator, University of Leipzig
ClinicalTrials.gov Identifier: NCT00510588     History of Changes
Other Study ID Numbers: 0815-2007
First Submitted: August 1, 2007
First Posted: August 2, 2007
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