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Health Effects of Recreational Soccer in Type 2 Diabetic Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636349
First Posted: July 10, 2012
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jakob Friis Schmidt, University of Copenhagen
  Purpose

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


Condition Intervention
Type 2 Diabetes Hypertension Obesity Metabolic Syndrome Other: soccer exercise or continued daily lifestyle

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men

Resource links provided by NLM:


Further study details as provided by Jakob Friis Schmidt, University of Copenhagen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 22
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Soccer training
No Intervention: Control group
10 subjects serve as a control group with no change in lifestyle in the study period

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636349


Locations
Denmark
University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: jakob friis schmidt, MD University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jakob Friis Schmidt, MD PhD student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01636349     History of Changes
Other Study ID Numbers: H-2-2011-088
31964 ( Other Grant/Funding Number: F-MARC )
First Submitted: July 5, 2012
First Posted: July 10, 2012
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Jakob Friis Schmidt, University of Copenhagen:
Type 2 diabetes
hypertension
obesity
metabolic syndrome

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism