MedDataX Logo

Marathon Runners Compared to Sedentary Matched Control Subjects

NCT ID: NCT02001805

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators wish to compare very active runners in healthy untrained control subjects on a number of parameters.

The project aims to understand the underlying mechanisms by which physical inactivity causes diseases. This the investigators will study the full spectrum of physical activity, from the most inert of the most active people. The investigators have already collected muscle biopsies and established stem cells from people with Type 2 diabetes, obese healthy and normal weight healthy. In this study, the investigators will establish a cohort of highly physically active marathon runners. In a case-control design, the investigators compare muscle stem cell function across the entire spectrum of physical activity / inactivity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There has never been as much focus on running as in these days. With the knowledge the investigators have today, there is reason to believe that it is healthy to run both in a physical sense, but perhaps also in terms of brain function. However, there has not previously carried out extensive comparative studies of very active runners and healthy untrained control subjects. In this project the investigators will characterize the degree of training in subjects as the investigators will carry out various forms of physiological studies on the subjects' fitness level. The investigators will examine whether there is a linkage between training level and brain function.

The investigators will also examine muscle function at the molecular level. The investigators will isolate stem cells (satellite cells) from muscles biopsy and establish primary muscle cell cultures. By electrical stimulation of these cells in vitro, the investigators can emulate a muscle contraction as during physical activity. The investigators will test the overall hypothesis that physical activity affects stem cell function.

The investigators will further study whether epigenetic phenomena (methylation) of selected DNA sequences are sensitive to training level.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Marathon runners

Very active runners that have been running \> 10 marathons, 2 within the last year, or an amount of 50 km/week for the last 5 years

No interventions assigned to this group

Control subjects

Healthy normal weight control subjects, with a low activity level \< 1 hour phsyical activity pr. week. They are matched with runners on age, BMI and gender

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 10 marathons, 2 within the last year or 50 km/week the last 5 years

Exclusion Criteria

* smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Augustinus Foundation, Denmark.

OTHER

Sponsor Role collaborator

Inge Holm

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Inge Holm

Head of Section CIM

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bente K Pedersen, Doctor

Role: STUDY_DIRECTOR

Center of Inflammation and Metabolism

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center of Inflammation and Metabolism, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Louise S Hansen, Cand. Scient

Role: CONTACT

Phone: 35450746

Email: [email protected]

Matthew Laye, Post doc

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Marathon Cohorte

Identifier Type: -

Identifier Source: org_study_id