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Trial record 2 of 5 for:    stem cell kidney | ( Map: Denmark )

Marathon Runners Compared to Sedentary Matched Control Subjects

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ClinicalTrials.gov Identifier: NCT02001805
Recruitment Status : Unknown
Verified November 2013 by Inge Holm, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
The Augustinus Foundation, Denmark.
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark

Brief Summary:

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.


Condition or disease
Type 2 Diabetes

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fitness, Glucosemetabolism, Cognitive Function, Bodycomposition and Muscular Function in Active Runners and Matched Controls
Study Start Date : December 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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
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



Primary Outcome Measures :
  1. Fitness [ Time Frame: one day ]
    Lactate threshold VO2max Running economy Lactate Peak

  2. Cognitive Function [ Time Frame: one day ]
    Memory, concentration, personality, intelligence

  3. Blood [ Time Frame: one day ]
    3 hour Oral Glucose Tolerance test (glucose, insulin, c-peptide) Fasting blood measurements ( lever, kidney, immune system, colesterol parameters) DNA

  4. Muscle biopsy [ Time Frame: one day ]
    Gene transcription Methylation

  5. Body Composition [ Time Frame: one day ]
    DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs


Secondary Outcome Measures :
  1. Activity level and diet [ Time Frame: 7 days ]
    Subjects are carrying a step pedometer for 7 days They are registrering their diet for 4 days They are answering questionaires about daily activity level and health now and in the past


Biospecimen Retention:   Samples With DNA
Whole blood, plasma, muscle tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Runners with high amount of training
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001805


Contacts
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Contact: Louise S Hansen, Cand. Scient 35450746 louise_seier_84@hotmail.com
Contact: Matthew Laye, Post doc mjlaye@gmail.com

Locations
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Denmark
Center of Inflammation and Metabolism, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Matthew Laye, Post Doc         
Sub-Investigator: Louise S Hansen, Cand Scient         
Sub-Investigator: Mille B Nielsen, Stud. Med         
Sponsors and Collaborators
Inge Holm
The Augustinus Foundation, Denmark.
Investigators
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Study Director: Bente K Pedersen, Doctor Center of Inflammation and Metabolism

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Responsible Party: Inge Holm, Head of Section CIM, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02001805     History of Changes
Other Study ID Numbers: Marathon Cohorte
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: November 2013