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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510705

Acronym

KFO

Enrollment

Registered

2007-08-02

Start date

2007-07-31

Completion date

Unknown

Last updated

2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Glucose Tolerance, Obesity, Severe Coronary Artery Disease

Keywords

adiposity

Brief summary

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.

Interventions

OTHERexercise training

physical exercise training on a bicycle ergometer daily for 4 weeks

OTHERexercise training + metformin

physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks

OTHERexercise training + glitazone

physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 75 Years

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%

Design outcomes

Primary

Measure	Time frame
change in endothelial function in severe coronary artery disease	4 weeks

Secondary

Measure	Time frame
change in metabolic parameters	4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026