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Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease (KFO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00510705
First received: August 1, 2007
Last updated: July 11, 2008
Last verified: June 2008
History of Changes
  Purpose

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this 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 (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.


Condition Intervention
Severe Coronary Artery Disease
Obesity
Impaired Glucose Tolerance
 Other: exercise training
Other: exercise training + metformin
Other: exercise training + glitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • change in endothelial function in severe coronary artery disease [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in metabolic parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Regular physical exercise training alone
 Other: exercise training
physical exercise training on a bicycle ergometer daily for 4 weeks
2
Regular physical exercise training + metformin
 Other: exercise training + metformin
physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
3
Regular physical exercise training + glitazone
 Other: exercise training + glitazone
physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
No Intervention: 4
Control

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Either impaired glucose tolerance (2 hour plasma glucose concentration > 7.8 and < 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( > 6.0 and < 7.0 mmol/L)
  • Body mass index (BMI) > 25
  • Severe coronary artery disease determined by coronary angiography
  • Male patients aged 35-75 years

Exclusion Criteria:

  • Diabetes mellitus type I
  • Diabetes mellitus type II 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
  • Myocardial infarction within the last 4 weeks
  • Reduced left-ventricular systolic function < 30%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510705

Contacts
Contact: Axel Linke, MD 0049-341-8651672 linkea@medizin.uni-leipzig.de

Locations
Germany
University of Leipzig - Heart Center Recruiting
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Gerhard Schuler, Prof. of Medicine University of Leipzig
  More Information

No publications provided

Responsible Party: Prof. Gerhard Schuler, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00510705     History of Changes
Other Study ID Numbers: 0816-2007
Study First Received: August 1, 2007
Last Updated: July 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
adiposity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Obesity
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013