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

Sponsor

University of Leipzig (Other)

Overall Status

Completed

CT.gov ID

NCT00510588

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 regular physical exercise training	Other: training regular physical exercise training for 6 months
Other: 2 regular physical exercise training + metformin	Other: training + metformin regular physical exercise training in combination with metformin for 6 months
Other: 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

Outcome Measures

Primary Outcome Measures

change in endothelial function in patients with stable coronary artery disease [6 months]

Secondary Outcome Measures

change in metabolic parameters [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 %