Health Effects of Recreational Soccer in Type 2 Diabetic Men

Study Overview
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Brief Summary
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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

Official Title
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Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men

Conditions
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Type 2 Diabetes, Hypertension, Obesity, Metabolic Syndrome

Intervention / Treatment
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* Other: soccer exercise or continued daily lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes diagnosed 35-60 years old men Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recreational soccer training<br>12 men participate in recreational soccer training for 6 months | Other: soccer exercise or continued daily lifestyle<br>* Recreational soccer or continued unchanged lifestyle<br>* Other names: Soccer training;|
| No Intervention: Control group<br>10 subjects serve as a control group with no change in lifestyle in the study period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac adaptations | All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler | 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 | Data analysis after baseline, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | All subjects are examined with peripheral arterial tonometri (endopat). Plasma samples and muscle biopsies are analyzed for relevant markers of vascular function | 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 | Data analysis after baseline, 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, hypertension, obesity, metabolic syndrome