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

NCT ID: NCT00510705

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Coronary Artery Disease Obesity Impaired Glucose Tolerance

Keywords

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adiposity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Regular physical exercise training alone

Group Type OTHER

exercise training

Intervention Type OTHER

physical exercise training on a bicycle ergometer daily for 4 weeks

2

Regular physical exercise training + metformin

Group Type OTHER

exercise training + metformin

Intervention Type OTHER

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

3

Regular physical exercise training + glitazone

Group Type OTHER

exercise training + glitazone

Intervention Type OTHER

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

4

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise training

physical exercise training on a bicycle ergometer daily for 4 weeks

Intervention Type OTHER

exercise training + metformin

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

Intervention Type OTHER

exercise training + glitazone

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

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig - University Hospital

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Axel Linke

Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Schuler, Prof. of Medicine

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig - Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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0816-2007

Identifier Type: -

Identifier Source: org_study_id