Health Effects of Recreational Soccer in Type 2 Diabetic Men

December 6, 2012 updated by: Jakob Friis Schmidt, University of Copenhagen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular function
Time Frame: Data analysis after baseline, 12 and 24 weeks
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
Time Frame: Data analysis after baseline, 12 and 24 weeks
HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
Data analysis after baseline, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: jakob friis schmidt, MD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-088
  • 31964 (Other Grant/Funding Number: F-MARC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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