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

December 2, 2014 updated by: Robert Hoellriegel, University of Leipzig
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 %

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 4
Control
Other: 1
regular physical exercise training
Other: training
regular physical exercise training for 6 months
Other: 2
regular physical exercise training + metformin
Other: training + metformin
regular physical exercise training in combination with metformin for 6 months
Other: 3
regular physical exercise training + glitazon
Other: training + glitazon
regular physical exercise training in combination with a glitazon for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in endothelial function in patients with stable coronary artery disease
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in metabolic parameters
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Gerhard Schuler, Prof. of medicine, Heart Center Leipzig - University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0815-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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