Type 2 DiabetesNCT02001805
Marathon Runners Compared to Sedentary Matched Control Subjects
An observational study of Type 2 Diabetes, run by Inge Holm at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Runners with high amount of training
Who may be able to join
- 10 marathons, 2 within the last year or 50 km/week the last 5 years
Who cannot join
- smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse
Trial locations and contacts
1 site in 1 country.
Matthew Laye, Post doc contact
Denmark1 site, 1 recruiting
- Recruiting
Center of Inflammation and Metabolism, Rigshospitalet
Copenhagen, 2100
Matthew Laye, Post Doc
Louise S Hansen, Cand Scient
About this study
Official title: Fitness, Glucosemetabolism, Cognitive Function, Bodycomposition and Muscular Function in Active Runners and Matched Controls
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness
Lactate threshold VO2max Running economy Lactate Peak
Measured: one day
Cognitive Function
Memory, concentration, personality, intelligence
Measured: one day
Blood
3 hour Oral Glucose Tolerance test (glucose, insulin, c-peptide) Fasting blood measurements ( lever, kidney, immune system, colesterol parameters) DNA
Measured: one day
Muscle biopsy
Gene transcription Methylation
Measured: one day
Body Composition
DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs
Measured: one day
Secondary outcomes (1)
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inge Holm
- Sponsor type
- University, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark.
- Responsible party
- Sponsor-investigator, Inge Holm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, Doctor, Study director, Center of Inflammation and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001805
- Sponsor's protocol ID
- Marathon Cohorte
- Status last verified
- Nov 2013
- First submitted
- 18 May 2011
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness, Glucosemetabolism, Cognitive Function, Bodycomposition and Muscular Function in Active Runners and Matched Controls
- ClinicalTrials.gov ID
- NCT02001805
- Acronym / sponsor ID
- Marathon Cohorte
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Inge HolmUniversity, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark.
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Runners with high amount of training
Key inclusion criteria (1 listed)
- 10 marathons, 2 within the last year or 50 km/week the last 5 years
Key exclusion criteria (1 listed)
- smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Activity level and diet
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Laye, Post doc contact
Bente K Pedersen, Doctor study director
Center of Inflammation and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Inge Holm at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise S Hansen, Cand. Scient (35450746, louise_seier_84@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness (time frame: one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.