Health Effects of Recreational Soccer in Type 2 Diabetic Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jakob Friis Schmidt, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01636349
First received: July 5, 2012
Last updated: December 6, 2012
Last verified: December 2012

July 5, 2012
December 6, 2012
November 2011
December 2012   (final data collection date for primary outcome measure)
  • Cardiac adaptations [ Time Frame: Analysis of data at baseline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
  • muscular adaptations [ Time Frame: Data analysis after baseline, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
    muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
  • Cardiac adaptations [ Time Frame: november 2011 - october 2012 ] [ Designated as safety issue: No ]
    All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
  • muscular adaptations [ Time Frame: november 2011 - october 2012 ] [ Designated as safety issue: Yes ]
    muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
Complete list of historical versions of study NCT01636349 on ClinicalTrials.gov Archive Site
  • Vascular function [ Time Frame: Data analysis after baseline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
  • Vascular function [ Time Frame: november 2011-october 2012 ] [ Designated as safety issue: No ]
    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: november 2011- october 2012 ] [ Designated as safety issue: No ]
    HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
Not Provided
Not Provided
 
Health Effects of Recreational Soccer in Type 2 Diabetic Men
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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Hypertension
  • Obesity
  • Metabolic Syndrome
Other: soccer exercise or continued daily lifestyle
Recreational soccer or continued unchanged lifestyle
Other Name: Soccer training
  • Experimental: Recreational soccer training
    12 men participate in recreational soccer training for 6 months
    Intervention: Other: soccer exercise or continued daily lifestyle
  • No Intervention: Control group
    10 subjects serve as a control group with no change in lifestyle in the study period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Male
35 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01636349
H-2-2011-088, 31964
Yes
Jakob Friis Schmidt, University of Copenhagen
University of Copenhagen
Not Provided
Principal Investigator: jakob friis schmidt, MD University of Copenhagen
University of Copenhagen
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP