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

Obesity Clinical Trial

— KFO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510588
• Other study ID #: 0815-2007
• Status: Completed
• Phase: N/A
• First received: August 1, 2007
• Last updated: December 2, 2014
• Start date: July 2007
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

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 %

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Glucose Intolerance
• Impaired Glucose Tolerance
• Myocardial Ischemia
• Obesity
• Stable Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Germany	University of Leipzig - heart center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in endothelial function in patients with stable coronary artery disease		6 months	No
Secondary	change in metabolic parameters		6 months	No