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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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
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
- Fitness [ Time Frame: one day ]Lactate threshold VO2max Running economy Lactate Peak
- Cognitive Function [ Time Frame: one day ]Memory, concentration, personality, intelligence
- 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
- Muscle biopsy [ Time Frame: one day ]Gene transcription Methylation
- Body Composition [ Time Frame: one day ]DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs
- 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
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
|Contact: Louise S Hansen, Cand. Scientemail@example.com|
|Contact: Matthew Laye, Post firstname.lastname@example.org|
|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|
|Study Director:||Bente K Pedersen, Doctor||Center of Inflammation and Metabolism|