Health Effects of Recreational Soccer in Type 2 Diabetic Men

Obesity Clinical Trial

Official title:

Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636349
• Other study ID #: H-2-2011-088
• Secondary ID: 31964
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: December 6, 2012
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Etics Commitee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Type 2 Diabetes

Intervention

Other:
• soccer exercise or continued daily lifestyle
Recreational soccer or continued unchanged lifestyle

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac adaptations	All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler	Analysis of data at baseline, 12 and 24 weeks	No
Primary	muscular adaptations	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	Yes
Secondary	Vascular function	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	No
Secondary	glycaemic control	HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively	Data analysis after baseline, 12 and 24 weeks	No