Marathon Runners Compared to Sedentary Matched Control Subjects

Type 2 Diabetes Clinical Trial

Official title:

Fitness, Glucosemetabolism, Cognitive Function, Bodycomposition and Muscular Function in Active Runners and Matched Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02001805
• Other study ID #: Marathon Cohorte
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2011
• Last updated: November 28, 2013
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Rigshospitalet, Denmark
• Contact: Louise S Hansen, Cand. Scient
• Phone: 35450746
• Email: louise_seier_84[@]hotmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
Denmark	Center of Inflammation and Metabolism, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Inge Holm	The Augustinus Foundation, Denmark.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitness	Lactate threshold VO2max Running economy Lactate Peak	one day	No
Primary	Cognitive Function	Memory, concentration, personality, intelligence	one day	No
Primary	Blood	3 hour Oral Glucose Tolerance test (glucose, insulin, c-peptide) Fasting blood measurements ( lever, kidney, immune system, colesterol parameters) DNA	one day	Yes
Primary	Muscle biopsy	Gene transcription Methylation	one day	Yes
Primary	Body Composition	DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs	one day	No
Secondary	Activity level and diet	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	7 days	No