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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00500773
Other study ID # 1807/07
Secondary ID
Status Completed
Phase N/A
First received July 11, 2007
Last updated April 30, 2014
Start date July 2007
Est. completion date May 2008

Study information

Verified date April 2014
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the cardiovascular risk involved in the exertional exercise of marathon running. The researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. Subclinical injuries to heart and arteries are being investigated in different groups of runners, including obese participants.


Description:

Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

The researchers aim to define the critical role of inflammatory markers and cardiovascular risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

The study groups are divided into average trained runners (40 km/week), average trained obese runners and highly trained runners (> 70km/week). Training programmes are supervised by professional coaches. Individual scientific marathon contests are organized for the assessments.

Diagnostic tools include measurements of pulse wave velocity and heart rate turbulence, echocardiography and, for the first time, MRI-scans pre- and post marathon running. Additionally, cardiovascular markers such as endothelial progenitor cells (EPCs)and adiponectin are measured. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- Men aged 30-60 years

- Obese subjects: BMI > 27 and waist circumference > 102cm

Exclusion Criteria:

- manifested heart disease

- insulin dependent diabetes mellitus

- multiple drug therapy

- GFR < 60 ml/min.

- claustrophobia

- metal implants

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Prevention and Sportsmedicine, Technical University of Munich Connollystrasse 32, Munich Bavaria

Sponsors (2)

Lead Sponsor Collaborator
Technische Universität München Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

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