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

University of Leipzig

Status: Terminated

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

Treatments: Other: exercise training; Other: exercise training + metformin; Other: exercise training + glitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00510705

0816-2007

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 4 patient groups

1

Other group

Description:

Regular physical exercise training alone

Treatment:

Other: exercise training

2

Other group

Description:

Regular physical exercise training + metformin

Treatment:

Other: exercise training + metformin

3

Other group

Description:

Regular physical exercise training + glitazone

Treatment:

Other: exercise training + glitazone

4

No Intervention group

Description:

Control