Type 2 DiabetesNCT01636349
Health Effects of Recreational Soccer in Type 2 Diabetic Men
A study testing soccer exercise or continued daily lifestyle in people with Type 2 Diabetes and Hypertension, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Obesity
- What is being tested?
- soccer exercise or continued daily lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- 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 35 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes diagnosed
- 35-60 years old men
Who cannot join
- Smoker
- Ischaemic heart Disease
- Congestive heart failure
- Joint or limp pains to an extent where recreational soccer can not be performed.
- Apoplexia.
- Anticoagulant therapy (aspirin accepted)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men
The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively.
The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men
- Conditions
- Type 2 Diabetes, Hypertension, Obesity, Metabolic Syndrome
- Being tested
- soccer exercise or continued daily lifestyle
- Keywords
- Type 2 diabetes, hypertension, obesity, metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soccer exercise or continued daily lifestyleOther
Also called Soccer training
Recreational soccer or continued unchanged lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Recreational soccer training | Experimental | 12 men participate in recreational soccer training for 6 months Receives: Other: soccer exercise or continued daily lifestyle |
| Control group | No intervention | 10 subjects serve as a control group with no change in lifestyle in the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac adaptations
All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
Measured: Analysis of data at baseline, 12 and 24 weeks
muscular adaptations
muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
Measured: Data analysis after baseline, 12 and 24 weeks
Secondary outcomes (2)
Vascular function
All subjects are examined with peripheral arterial tonometri (endopat). Plasma samples and muscle biopsies are analyzed for relevant markers of vascular function
Measured: Data analysis after baseline, 12 and 24 weeks
glycaemic control
HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
Measured: Data analysis after baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Friis Schmidt, University of Copenhagen
- Investigators
- jakob friis schmidt, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636349
- Sponsor's protocol ID
- H-2-2011-088
- Other IDs
- 31964
- Status last verified
- Dec 2012
- First submitted
- 5 Jul 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen TR, Schmidt JF, Thomassen M, Hornstrup T, Frandsen U, Randers MB, Hansen PR, Krustrup P, Bangsbo J. A preliminary study: effects of football training on glucose control, body composition, and performance in men with type 2 diabetes. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:43-56. doi: 10.1111/sms.12259. Epub 2014 Jun 5.
PubMed 24903461
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men
- ClinicalTrials.gov ID
- NCT01636349
- Acronym / sponsor ID
- H-2-2011-088
- Conditions
- Type 2 Diabetes, Hypertension, Obesity, Metabolic Syndrome
- Keywords
- Type 2 diabetes, hypertension, obesity, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jul 2012 (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 present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively.
The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recreational soccer training | Experimental | Other: soccer exercise or continued daily lifestyle12 men participate in recreational soccer training for 6 months |
| Control group | No intervention | –10 subjects serve as a control group with no change in lifestyle in the study period |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type 2 diabetes diagnosed
- 35-60 years old men
Key exclusion criteria (6 listed)
- Smoker
- Ischaemic heart Disease
- Congestive heart failure
- Joint or limp pains to an extent where recreational soccer can not be performed.
- Apoplexia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soccer exercise or continued daily lifestyleAlso: Soccer trainingRecreational soccer or continued unchanged lifestyle | Other | Recreational soccer training |
Primary outcome
Cardiac adaptations
Time frame: Analysis of data at baseline, 12 and 24 weeks
All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
muscular adaptations
Time frame: Data analysis after baseline, 12 and 24 weeks
muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
2 secondary outcomes
Vascular function
Time frame: Data analysis after baseline, 12 and 24 weeks
glycaemic control
Time frame: Data analysis after baseline, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Derived from this study: PubMed 24903461Andersen TR, Schmidt JF, Thomassen M, Hornstrup T, Frandsen U, Randers MB, Hansen PR, Krustrup P, Bangsbo J. A preliminary study: effects of football training on glucose control, body composition, and performance in men with type 2 diabetes. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:43-56. doi: 10.1111/sms.12259. Epub 2014 Jun 5.
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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.
jakob friis schmidt, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soccer exercise or continued daily lifestyle in people with Type 2 Diabetes and Hypertension, run by University of Copenhagen 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 7 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac adaptations (time frame: Analysis of data at baseline, 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636349, which also lists 1 linked publication.
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 7 Dec 2012.