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

University of Leipzig

Status: Completed

Conditions: Impaired Glucose Tolerance; Stable Coronary Artery Disease; Obesity

Treatments: Other: training + metformin; Other: training + glitazon; Other: training

Study type: Interventional

Funder types: Other

Identifiers

NCT00510588

0815-2007

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 35 to 75 years old

Volunteers: No 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 %

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

1

Other group

Description:

regular physical exercise training

Treatment:

Other: training

2

Other group

Description:

regular physical exercise training + metformin

Treatment:

Other: training + metformin

3

Other group

Description:

regular physical exercise training + glitazon

Treatment:

Other: training + glitazon

4

No Intervention group

Description:

Control