Back to resultsHealth Effects of Recreational Soccer in Type 2 Diabetic Men
Primary Purpose
Type 2 Diabetes, Hypertension, Obesity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
soccer exercise or continued daily lifestyle
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 diabetes, hypertension, obesity, metabolic syndrome
Eligibility Criteria
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)
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Recreational soccer training
Control group
Arm Description
12 men participate in recreational soccer training for 6 months
10 subjects serve as a control group with no change in lifestyle in the study period
Outcomes
Primary Outcome Measures
Cardiac adaptations
All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
muscular adaptations
muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
Secondary Outcome Measures
Vascular function
All subjects are examined with peripheral arterial tonometri (endopat). Plasma samples and muscle biopsies are analyzed for relevant markers of vascular function
glycaemic control
HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
Full Information
NCT ID
NCT01636349
First Posted
July 5, 2012
Last Updated
December 6, 2012
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01636349
Brief Title
Health Effects of Recreational Soccer in Type 2 Diabetic Men
Official Title
Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hypertension, Obesity, Metabolic Syndrome
Keywords
Type 2 diabetes, hypertension, obesity, metabolic syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recreational soccer training
Arm Type
Experimental
Arm Description
12 men participate in recreational soccer training for 6 months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
10 subjects serve as a control group with no change in lifestyle in the study period
Intervention Type
Other
Intervention Name(s)
soccer exercise or continued daily lifestyle
Other Intervention Name(s)
Soccer training
Intervention Description
Recreational soccer or continued unchanged lifestyle
Primary Outcome Measure Information:
Title
Cardiac adaptations
Description
All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
Time Frame
Analysis of data at baseline, 12 and 24 weeks
Title
muscular adaptations
Description
muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
Time Frame
Data analysis after baseline, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Vascular function
Description
All subjects are examined with peripheral arterial tonometri (endopat). Plasma samples and muscle biopsies are analyzed for relevant markers of vascular function
Time Frame
Data analysis after baseline, 12 and 24 weeks
Title
glycaemic control
Description
HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
Time Frame
Data analysis after baseline, 12 and 24 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jakob friis schmidt, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24903461
Citation
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.
Results Reference
derived
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Health Effects of Recreational Soccer in Type 2 Diabetic Men
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