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

Primary Purpose

Severe Coronary Artery Disease, Obesity, Impaired Glucose Tolerance

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

exercise training

exercise training + metformin

exercise training + glitazone

About this trial

This is an interventional prevention trial for Severe Coronary Artery Disease focused on measuring adiposity

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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%

Sites / Locations

University of Leipzig - Heart Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

No Intervention

Arm Label

Arm Description

Regular physical exercise training alone

Regular physical exercise training + metformin

Regular physical exercise training + glitazone

Control

Outcomes

Primary Outcome Measures

change in endothelial function in severe coronary artery disease

Secondary Outcome Measures

change in metabolic parameters

Full Information

NCT ID

NCT00510705

First Posted

August 1, 2007

Last Updated

November 23, 2020

Sponsor

University of Leipzig

Collaborators

Heart Center Leipzig - University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00510705

Brief Title

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

Acronym

KFO

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Leipzig

Collaborators

Heart Center Leipzig - University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Coronary Artery Disease, Obesity, Impaired Glucose Tolerance

Keywords

adiposity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Regular physical exercise training alone

Arm Title

Arm Type

Other

Arm Description

Regular physical exercise training + metformin

Arm Title

Arm Type

Other

Arm Description

Regular physical exercise training + glitazone

Arm Title

Arm Type

No Intervention

Arm Description

Control

Intervention Type

Other

Intervention Name(s)

exercise training

Intervention Description

physical exercise training on a bicycle ergometer daily for 4 weeks

Intervention Type

Other

Intervention Name(s)

exercise training + metformin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

exercise training + glitazone

Intervention Description

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

Primary Outcome Measure Information:

Title

change in endothelial function in severe coronary artery disease

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

change in metabolic parameters

Time Frame

4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Schuler, Prof. of Medicine

Organizational Affiliation

Heart Center Leipzig - University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Leipzig - Heart Center

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

12. IPD Sharing Statement

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

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