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

NCT ID: NCT00510588

Last Updated: 2014-12-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-10-31

Brief Summary

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Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. 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.

Detailed Description

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Conditions

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Stable Coronary Artery Disease Obesity Impaired Glucose Tolerance

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

Group Type OTHER

training

Intervention Type OTHER

regular physical exercise training for 6 months

2

regular physical exercise training + metformin

Group Type OTHER

training + metformin

Intervention Type OTHER

regular physical exercise training in combination with metformin for 6 months

3

regular physical exercise training + glitazon

Group Type OTHER

training + glitazon

Intervention Type OTHER

regular physical exercise training in combination with a glitazon for 6 months

4

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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training

regular physical exercise training for 6 months

Intervention Type OTHER

training + metformin

regular physical exercise training in combination with metformin for 6 months

Intervention Type OTHER

training + glitazon

regular physical exercise training in combination with a glitazon for 6 months

Intervention Type OTHER

Eligibility Criteria

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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 %
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Robert Hoellriegel

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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0815-2007

Identifier Type: -

Identifier Source: org_study_id