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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Copenhagen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   35 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 5, 2012
Last Updated: December 6, 2012
Health Authority: Denmark: Danish Etics Commitee

Keywords provided by University of Copenhagen:
Type 2 diabetes
hypertension
obesity
metabolic syndrome

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 21, 2014