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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00510588
Other study ID # 0815-2007
Secondary ID
Status Completed
Phase N/A
First received August 1, 2007
Last updated December 2, 2014
Start date July 2007
Est. completion date October 2013

Study information

Verified date December 2014
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
training
regular physical exercise training for 6 months
training + metformin
regular physical exercise training in combination with metformin for 6 months
training + glitazon
regular physical exercise training in combination with a glitazon for 6 months

Locations

Country Name City State
Germany University of Leipzig - heart center Leipzig

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in endothelial function in patients with stable coronary artery disease 6 months No
Secondary change in metabolic parameters 6 months No
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