Clinical trial NCT00500773: Investigation of Cardiac Function and Cardiovascular Risk Factors in Marathon Runners- The Munich Marathon Study
Official title: Investigation of Myocardial Injury, Ventricular Dysfunction and Cardiovascular Risk Factors in Different Groups of Marathon Runners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Modes of Exercise and Myocardial and Endothelial Function
Microcirculation
Subclinical Endorgan Damage
Obesity
Keywords: cardiovascular risc factors
inflammation
aerobic and exertional exercise
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2007-07-13
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male marathon runners with no more than one treated cardiovascular risk factor aged 30-60 years. Participation of at least a 1/2 marathon in recent history.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Connollystrasse 32, Munich
country: Germany
facility: Department of Prevention and Sportsmedicine, Technical University of Munich
state: Bavaria
Study officials:
affiliation: Department of Prevention and Sportmedicine, Technical University Munich
name: Henner Hanssen, MD
role: PRINCIPAL_INVESTIGATOR
References: